CURRICULUM VITAE

MARK J. RATAIN, M.D.

 

Date of Birth: November 23, 1954

Place of Birth: Washington, D.C.

Marital Status: Married


Mailing Address:

Mark J. Ratain, M.D.

University of Chicago Pritzker School of Medicine

MC2115

5841 S. Maryland Avenue

Chicago, Illinois 60637

Email: mratain@medicine.bsd.uchicago.edu

Telephone:(773) 702-4400

Voicemail:(773) 702-1815

Fax:(773) 702-3969


Education

1976 Harvard University, A.B. (biochemical sciences, magna cum laude)

1980 Yale University School of Medicine, M.D. (thesis -"Elicitation of the late nasal and cutaneous response: the possible role of eosinophils and basophils")


Professional Positions

1972-1977 Computer programmer/systems analyst - part-time. System Sciences, Inc., Bethesda, MD

1980-1981 Intern, Osler Medical Service, Johns Hopkins Hospital, Baltimore, MD

1981-1983 Resident, Osler Medical Service, Johns Hopkins Hospital, Baltimore, MD

1983-1986 Fellow, Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, IL

1986-1988 Associate Attending Member, Department of Medicine, Division of Hematology/Oncology, Michael Reese Hospital and Medical Center, Chicago, IL

1986-1987 Instructor, Department of Medicine, Section of Hematology/Oncology, and Committee on Clinical Pharmacology, University of Chicago, Chicago, IL

1987-1991 Assistant Professor, Department of Medicine, Section of Hematology/Oncology, and Committee on Clinical Pharmacology, University of Chicago, Chicago, IL

1988-1989 Attending Member, Department of Medicine, Division of Hematology/Oncology, Michael Reese Hospital and Medical Center, Chicago, IL

1988-1992 Director of Clinical Pharmacology, Section of Hematology/Oncology, University of Chicago, Chicago, IL

1991-1995 Director, Developmental Therapeutics Program, Cancer Research Center, University of Chicago, Chicago, IL

1991-1995 Associate Professor, Department of Medicine, Section of Hematology/Oncology, Committee on Clinical Pharmacology, and Cancer Research Center, University of Chicago, Chicago, IL

1992- Chairman, Committee on Clinical Pharmacology, University of Chicago, Chicago, IL

1993- Senior Scholar, The Center for Clinical Medical Ethics, University of Chicago, Chicago, IL

1995-2000 Professor, Department of Medicine, Section of Hematology/Oncology, Committee on

1995-2000 Clinical Pharmacology, and Cancer Research Center, University of Chicago, Chicago, IL

Co-Director, Clinical and Experimental Therapeutics Program, Cancer Research Center, University of Chicago, Chicago, IL

Associate Director for Clinical Sciences, Cancer Research Center, University of Chicago, Chicago, IL


Professional Services

1986 Ad Hoc Reviewer, Experimental Therapeutics Study Section, Division of Research Grants, National Institutes of Health

1988-1989 American Federation for Clinical Research, Medical School Representative

1989 First International Workshop on Pharmacodynamics of Anticancer Agents (Fontana, WI),Co-Organizer

1991 Special Review Committee, National Cancer Institute, National Institutes of Health

1992 Second International Workshop on Pharmacodynamics of Anticancer Agents (Eze, France), Co-Organizer

1993 Consultant Reviewer, Department of Veteran Affairs

1993 Ad Hoc Reviewer, National Cancer Institute, National Institutes of Health

1994 Special Study Section (Small Business Innovative Research Program), Division of Research Grants, National Institutes of Health

1994 Ad Hoc Reviewer, Dutch Cancer Society

1994 Ad Hoc Reviewer, The Cancer Society of New Zealand

1995 Third International Workshop on Pharmacodynamics of Anticancer Agents (Irvington, VA), Co-Organizer

1997-1998 Step 3 Test Material Development Committee for Utilization of Resources, United States Medical Licensing Examination, National Board of Medical Examiners

1997 Ad Hoc Reviewer, National Center for Research Resources, National

Institutes of Health

Fourth International Workshop on Pharmacodynamics of Anticancer Agents (Dunkeld, Scotland), Co-Organizer

Reviewer, Intramural Review Office, Pediatric Oncology Branch, National Cancer

Institute, National Institutes of Health

1999-2000 Clinical Oncology Special Emphasis Panel, Oncological Science Initial Review Group, Center for Scientific Review, National Institutes of Health.

Ad Hoc Reviewer, Joint Infrastructure Fund, Wellcome Trust

1999 Clinical Advisory Working Group, National Institute of General Medical Sciences, National Institutes of Health

1999 Ad Hoc Reviewer, Dutch Cancer Society

2000 Ad Hoc Reviewer, Joint Infrastructure Fund, Wellcome Trust

2000 Ad Hoc Reviewer, Drug Development Group, National Cancer Institute

2001 Fifth International Workshop on Pharmacodynamics of Anticancer Agents (Sea Island, GA), Co-Organizer


Regional Committees

1987-1992 New Agents Committee, Illinois Cancer Council

1987-1992 Biological Response Modifiers Committee, Illinois Cancer Council

1989-1992 Chemoprevention Committee, Illinois Cancer Council

1990-1991 Illinois Division Research Committee, American Cancer Society


National Committees

1988-1990 Chemotherapy Committee, Cancer and Leukemia Group B

1988-1992 Vice Chairperson, Hematologic and Neoplastic Diseases Section, American Society for Clinical Pharmacology and Therapeutics

1989-1998 Breast Committee, Cancer and Leukemia Group B

1989-1990 Ad Hoc Committee on Relations with Pharmaceutical Companies, Cancer and Leukemia Group B

1990-1992 Committee for Patient Advocacy, American Society of Clinical Oncology

1990-1997 Government Affairs Committee, American Society for Clinical Pharmacology and Therapeutics

1990-1993 Long Range Planning Committee, American Society for Clinical Pharmacology and Therapeutics

1990-1994 Chairman, Audit and Finance Committee, American Society of Clinical Oncology

1990-1994 Pharmacology and Experimental Therapeutics Committee, Cancer and Leukemia Group B

1990- Pharmacology and Molecular Mechanisms Group, European Organization for Research and Treatment of Cancer (Corresponding Member)

1991-1992 Ad Hoc Nominating Committee, Cancer and Leukemia Group B

1992-1995 Chairperson, Hematologic and Neoplastic Diseases Section, American Society for Clinical Pharmacology and Therapeutics

1992-1995 Committee on Coordination of Scientific Sections, American Society for Clinical Pharmacology and Therapeutics

1992-1993 Industrial Relations Committee, Cancer and Leukemia Group B

Scientific Program Committee, American Society for Clinical Pharmacology and Therapeutics

1993-1996 Executive Committee, Cancer and Leukemia Group B

1993- Board of Directors, Cancer and Leukemia Group B

1994-1997 Secretary-Treasurer, American Society of Clinical Oncology

1994-1997 Board of Directors, American Society of Clinical Oncology

1994-1997 Executive Committee, American Society of Clinical Oncology

1994-1998 Strategic Planning Committee, American Society of Clinical Oncology

1994-1996 Chair, Ad Hoc Committee on Conflict of Interest, Cancer and Leukemia Group B

1994- Chair, Pharmacology and Experimental Therapeutics Committee, Cancer and Leukemia Group B

1995-1996 Subchair for Clinical Pharmacology, Program Committee, American Society of Clinical Oncology

1995-1997 Board Liaison, Program Committee, American Society of Clinical Oncology

1995-1996 Nominating Committee, American Society for Clinical Pharmacology and Therapeutics

1995-1997 Board Liaison, Industry/Exhibits Committee, American Society of Clinical Oncology

1995 Ad Hoc Committee to Develop ASCO OnLine, American Society of Clinical Oncology

1995-1996 Program Committee, American Association for Cancer Research

1995-1997 Clinical Methods Workshop Program Committee, American Association for Cancer Research and American Society of Clinical Oncology

1995-2000 OnLine Committee, American Society of Clinical Oncology

1996-1998 Scientific Program Committee, American Society for Clinical Pharmacology and Therapeutics

1996 Chairman, Subcommittee on Phase I Clinical Trials, Public Issues Committee, American Society of Clinical Oncology

1996-1998 Chair, Conflict of Interest Committee, Cancer and Leukemia Group B

1996- Subspecialty Chairman for Clinical Pharmacology, Central Society for Clinical Research

1997-2000 OnLine Committee Liaison to Publications Committee, American Society of Clinical Oncology

1997- 1999 Chairman, Continuing Medical Education Committee, American Society of Clinical Oncology

1997- Board of Directors, American Society for Clinical Pharmacology and Therapeutics

Vice Chairperson, Government Affairs Committee, American Society for Clinical Pharmacology and Therapeutics

1998-2000 Chairperson, Committee on Coordination of Scientific Sections, American Society for Clinical Pharmacology and Therapeutics

1998- Executive Committee, American Society for Clinical Pharmacology and Therapeutics

1998- Communications and Public Relations Committee, American Society for Clinical Pharmacology and Therapeutics

1998-2000 Program Committee, American Society of Clinical Oncology

1998- Committee on Substance Abuse, American Society for Clinical Pharmacology and Therapeutics

Immediate Past Chair, Continuing Medical Education Committee, American Society of Clinical Oncology

2000- Founding Chair, Pharmacogenetics of Anticancer Agents Research Group

Chair, Pharmacogenetics Research Network Steering Committee, National Institute of General Medical Sciences

2000- Membership Committee, American Society for Clinical Pharmacology and Therapeutics

2000- Cancer Education Committee, American Society of Clinical Oncology

2000- Oncologic Disease Advisory Panel, U.S. Pharmacopeia


Institutional Committees

1987-1988 Intern Selection Committee, Department of Medicine, Michael Reese Hospital and Medical Center

1988-1989 Institutional Review Board, Alternate, Michael Reese Hospital and Medical Center

1988-1989 Pharmacy, Therapeutics and Antibiotic Committee, Michael Reese Hospital and Medical Center

1992-1995 Chairman, Office of Research Services Faculty Advisory Committee, University of Chicago, Biological Sciences Division

1992- Executive Committee, University of Chicago, Cancer Research Center

1992- Divisional Executive Committee, University of Chicago, Biological Sciences Division

1992- Clinical Chairmen's Committee, University of Chicago, Biological Sciences Division

1994-1998 American Cancer Society Institutional Research Grant Committee, University of Chicago, Cancer Research Center

1997-1998 Clinical Trials Director Search Committee, University of Chicago, Department of Health Studies

1998-1999 Co-Chair, Pharmacoepidemiology Search Committee, University of Chicago

1999-2000 Chair, Entrepreneurs Committee, University of Chicago, Department of Medicine

2000- Radiology Search Committee, University of Chicago, Biological Sciences Division

2000- Committee on Appointments and Promotions, University of Chicago, Biological Sciences

Division

2000- Chair, Clinical Research Working Group, University of Chicago, Department of Medicine

2000- Protocol Accrual Closure and Monitoring Committee University of Chicago, Cancer Research Center


Certification

1981 Diplomate, National Board of Medical Examiners

1983 Licensed Physician and Surgeon, State of Illinois

1983 Diplomate, American Board of Internal Medicine

1985 Diplomate, Medical Oncology, American Board of Internal Medicine

1986 Diplomate, Hematology, American Board of Internal Medicine

1993 Diplomate, American Board of Clinical Pharmacology


Professional Membership

1983- American College of Physicians (Fellow, 1990)

1986- American Association for the Advancement of Science

1986- American Society of Clinical Oncology

1986- American Federation for Clinical Research

1987- American Society for Clinical Pharmacology and Therapeutics

1988- American Association for Cancer Research

1988- American Society of Hematology

1990- Central Society for Clinical Research

1992- European Society for Medical Oncology


Honors and Awards

1975 Dreyfus Fellowship, Harvard University, Department of Biochemistry

1985 Central Society for Clinical Research, Trainee Award.

1994 Listed in The Best Doctors in America (Woodward/White)

1997 Listed in Chicagos Top Doctors, Chicago

1998 Listed in The Best Doctors in America (Woodward/White)

2000 Honorary Visiting Expert, Ministry of Health, Singapore

Editorial Services

1987-1988 Cancer Treatment Reports, Reviewer

1987- Clinical Pharmacology and Therapeutics, Reviewer

1987- Blood, Reviewer

1987- Cancer, Reviewer

1988- New England Journal of Medicine, Reviewer

1988- Leukemia, Reviewer

1989- Journal of the National Cancer Institute, Reviewer

1989-1991 Cancer Chemotherapy and Pharmacology, Reviewer

1989- Journal of Clinical Oncology, Reviewer

1989- Medical and Pediatric Oncology, Reviewer

1989- Cancer Research, Reviewer

1989- Leukemia and Lymphoma, Reviewer

1990-1996 Investigational New Drugs, Reviewer

1990- Cancer Chemotherapy and Pharmacology, Editorial Board

1992- Western Journal of Medicine, Reviewer

1992- Annals of Oncology, Reviewer

1991- Cancer Investigation, Reviewer

1993- Journal of the American Medical Association, Consultant Reviewer

1994-1996 Clinical Cancer Research, Editorial Board

1995- British Journal of Cancer, Reviewer

1995- Investigational New Drugs, Editorial Board

1996- American Journal of Respiratory and Critical Care Medicine, Reviewer

1996- Clinical Cancer Research, Associate Editor

European Journal of Cancer, Reviewer

Journal of Pharmacokinetics and Biopharmaceutics, Reviewer

British Journal of Clinical Pharmacology, Reviewer

1999- Clinical Pharmacology and Therapeutics, Editorial Advisory Committee

1999-2000 Current Opinion in Oncologic, Endocrine & Metabolic Investigational Drugs, Editorial Board

1999 Classic Papers and Current Comments: Clinical Pharmacology, Guest Editor

2000- The Pharmacogenetics Journal, Editorial Board

Journal of Clinical Oncology, Associate Editor

2000- American Journal of PharmacoGenomics, Honorary Editorial Board


Patents

1998 Camptothecin Drug Combinations and Methods with Reduced Side Effects

(inventors Mark J. Ratain & Elora Gupta), United States Patent No.: 5,786,344

(7/28/98)


Original Articles (Peer-Reviewed)

1. Ratain MJ, Golomb HM, Vardiman JW, Vokes EE, Jacobs RH, Daly K. Treatment of hairy cell leukemia with recombinant alpha-2-interferon. Blood 65, 644-648 (1985).

2. Bardawil RG, Groves C, Ratain MJ, Golomb HM, Vardiman JW. Changes in peripheral blood and bone marrow specimens following therapy with recombinant alpha2 interferon for hairy cell leukemia. Am J Clin Path 85, 194-201 (1986).

3. Golomb HM, Jacobs A, Fefer A, Ozer H, Thompson J, Portlock C, Ratain M, Golde D, Vardiman J, Burke J, Brady J, Bonnem E, Spiegel R. Alpha-2 interferon therapy of hairy cell leukemia: A multicenter study of 64 patients. J Clin Oncol 4, 900-905 (1986).

4. Schilsky RL, O'Laughlin K, Ratain MJ. Phase I clinical and pharmacological study of thymidine (NSC 21548) and cis-diamminedichloroplatinum (II) in patients with advanced cancer. Cancer Res 46, 4184-4188 (1986).

5. Ratain MJ, Vogelzang NJ. Phase I and pharmacological study of vinblastine by prolonged continuous infusion. Cancer Res 46, 4827-4830 (1986).

6. Bennett CL, Vogelzang NJ, Ratain MJ, Reich S. Hyponatremia and other toxic effects during a phase I trial of recombinant human gamma interferon and vinblastine. Cancer Treat Rep 70, 1081-1084 (1986).

7. Ratain MJ, Vogelzang NJ, Sinkule JA. Interpatient and intrapatient variability in vinblastine pharmacokinetics. Clin Pharmacol Ther 41, 61-67 (1987).

8. Ratain MJ, Golomb HM, Bardawil RG, Vardiman JW, Westbrook CA, Kaminer LS, Lembersky BC, Bitter MA, Daly K. Durability of responses to interferon alfa-2b in advanced hairy cell leukemia. Blood 69, 872-877 (1987).

9. Vokes EE, Bitter MA, Ratain MJ, Prystowsky MB, Daly K, Golomb HM. Flow cytometry in hairy cell leukemia before and during interferon alfa-2b therapy. Cancer 59, 1987-1991 (1987).

10. Ratain MJ, Vogelzang NJ. Limited sampling model for vinblastine pharmacokinetics. Cancer Treat Rep 71, 935-939 (1987).

11. Ratain MJ, Kaminer LS, Bitran JD, Larson RA, LeBeau MM, Skosey C, Purl S, Hoffman PC, Wade J, Vardiman JW, Daly K, Rowley JD, Golomb HM. Acute nonlymphocytic leukemia following etoposide and cisplatin combination chemotherapy for advanced non-small cell carcinoma of the lung. Blood 70, 1412-1417 (1987).

12. Vogelzang NJ, Ruane M, Ratain MJ, Dhowlatshahi K, Chodak GW. A programmable and implantable pumping system for systemic chemotherapy: A performance analysis in 52 patients. J Clin Oncol 5, 1968-1976 (1987).

13. Lembersky BC, Ratain MJ, Westbrook C, Golomb HM. Rapid response to 2'deoxycoformycin in advanced hairy cell leukemia after failure of interferons alpha and gamma. Amer J Hematol 27, 60-62 (1988).

14. Golomb HM, Ratain MJ, Fefer A, Thompson J, Golde DW, Ozer H, Portlock C, Silber R, Rappeport J, Bonnem E, Spiegel R, Tensen L, Burke JS, Vardiman JW. Randomized study of the duration of treatment with interferon alfa-2b in patients with hairy cell leukemia. J Natl Cancer Inst 80, 369-373 (1988).

15. Vardiman JW, Gilewski TA, Ratain MJ, Bitter MA, Bradlow BA, Golomb HM. Evaluation of Leu M-5 (CD11c) in hairy cell leukemia by the alkaline phosphatase anti-alkaline phosphatase technique. Am J Clin Path 90, 250-256 (1988).

16. Lembersky BC, Ratain MJ, Golomb HM. Skeletal complications in hairy cell leukemia: diagnosis and therapy. J Clin Oncol 6, 1280-1284 (1988).

17. Ratain MJ, Staubus AE, Schilsky RL, Malspeis L. Limited sampling models for amonafide (NSC 308847) pharmacokinetics. Cancer Res 48, 4127-4130 (1988).

18. Ackland SP, Choi KE, Ratain MJ, Egorin MJ, Williams SF, Sinkule JA, Bitran JD. Human plasma pharmacokinetics of thiotepa following administration of high-dose thiotepa and cyclophosphamide. J Clin Oncol 6, 1192-1196 (1988).

19. Ratain MJ, Vardiman JW, Barker CM, Golomb HM. Prognostic variables in hairy cell leukemia after splenectomy as initial therapy. Cancer 62, 2420-2424 (1988).

20. Ratain MJ, Golomb HM, Vardiman JW, Westbrook CA, Barker C, Hooberman A, Bitter MA, Daly K. Relapse after interferon alfa-2b therapy for hairy-cell leukemia: Analysis of prognostic variables. J Clin Oncol 6, 1714-1721 (1988).

21. Ratain MJ, Schilsky RL, Wojack BR, Simon T, Senekjian E, Vogelzang NJ. Hydroxyurea and etoposide: In vitro synergy and phase I clinical trial. J Natl Cancer Inst 80, 1412-1416 (1988).

22. Ackland SP, Ratain MJ, Vogelzang NJ, Choi KE, Ruane M, Sinkule JA. Pharmacokinetics and pharmacodynamics of long-term continuous-infusion doxorubicin. Clin Pharmacol Ther 45, 340-347 (1989).

23. Vokes EE, Schilsky RL, Choi KE, Magid DM, Guarnieri CM, Whaling SM, Ratain MJ, Weichselbaum RR, Panje WR. A randomized study of inpatient versus outpatient continuous infusion chemotherapy for patients with locally advanced head and neck cancer. Cancer 63, 30-36 (1989).

24. Ratain MJ, Schilsky RL, Choi KE, Guarnieri C, Grimmer D, Vogelzang NJ, Senekjian E, Liebner MA. Adaptive control of etoposide dosing: Impact of interpatient pharmacodynamic variability. Clin Pharmacol Ther 45, 226-233 (1989).

25. Choi KE, Ratain MJ, Williams SF, Golick JA, Beschorner JC, Fullem L, Bitran JD. Plasma pharmacokinetics of high-dose oral melphalan in patients treated with trialkylator chemotherapy and autologous bone marrow reinfusion. Cancer Res 49, 1318-1321 (1989).

26. Egorin MJ, Forrest A, Belani CP, Ratain MJ, Abrams JS, Van Echo DA. A limited sampling strategy for cyclophosphamide pharmacokinetics. Cancer Res 49, 3129-3133 (1989).

27. Moormeier J, Ratain MJ, Vardiman JW, Daly K, Golomb HM. Low dose interferon in hairy cell leukemia. J Natl Cancer Inst 81, 1172-1174 (1989).

28. Moormeier J, Westbrook CA, Ratain MJ, Golomb HM. Interferon alfa-2B antibodies and clinical resistance in a patient with hairy cell leukemia. Leukemia Lymphoma 1, 43-45 (1989).

29. Johnston C, Senekjian EK, Ratain MJ, Talerman A. Conservative management of primary cervical lymphoma using combination chemotherapy: a case report. Gynecol Oncol 35, 391-394 (1989).

30. Ratain MJ, Schilsky RL, Conley BA, Egorin MJ. Pharmacodynamics in cancer therapy. J Clin Oncol 8, 1739-1753 (1990).

31. Schilsky RL, Ratain MJ. Clinical pharmacokinetics of high dose leucovorin after intravenous and oral administration. J Natl Cancer Inst 82, 1411-1415 (1990).

32. Richards JM, Mick R, Latta JM, Daly K, Ratain MJ, Vardiman JW, Golomb HM. Serum soluble IL-2 receptor is associated with clinical and pathologic disease status in hairy cell leukemia. Blood 76, 1941-1945 (1990).

33. Ratain MJ, Robert J, van der Vijgh WJF. Limited sampling models for doxorubicin pharmacokinetics. J Clin Oncol 9, 871-876 (1991).

34. Vokes EE, Ratain MJ, Janisch L, Hoffman PC, Golomb HM, Schilsky RL. A phase I study of cisplatin, 5-fluorouracil and leucovorin with escalating doses of hydroxyurea in chemotherapy naive patients. Eur J Cancer 27, 217-218 (1991).

35. Golomb HM, Fefer A, Golde DW, Ozer H, Portlock C, Silber R, Rappeport J, Ratain MJ, Thompson J, Bonnem E, Spiegel R, Tensen L, Burke JS, Vardiman JW. Survival experience of 195 patients with hairy cell leukemia treated in a multi-institutional study with interferon-alfa 2b. Leukemia Lymphoma 4, 99-102 (1991).

36. Vokes EE, Raschko JW, Vogelzang NJ, Warfield EE, Ratain MJ, Doroshow JH, Schilsky RL. Five day infusion fluorodeoxyuridine with high dose oral leucovorin: A phase I study. Cancer Chemother Pharmacol 28, 69-73 (1991).

37. Ratain MJ, Mick R, Schilsky RL, Vogelzang NJ, Berezin F. Pharmacologically-based dosing of etoposide: A means of safely increasing dose-intensity. J Clin Oncol 9, 1480-1486 (1991).

38. Golomb HM, Ratain MJ, Fefer A, Thompson J, Portlock CS, Ozer H, Mick R, Chiavello J, Israel RJ, Bonnem EM. Low dose interferon alfa-2B for the induction of remission of hairy cell leukemia: A multi-institutional study of 49 patients. Leukemia Lymphoma 5, 335-340 (1991).

39. Platanias LC, Miller CB, Mick R, Hart RD, Ozer H, McEvilly JM, Jones RJ, Ratain MJ. Treatment of chemotherapy-induced anemia with recombinant human erythropoietin in cancer patients. J Clin Oncol 9, 2021-2026 (1991).

40. Ratain MJ, Mick R, Berezin F, Janisch L, Schilsky RL, Williams SF, Smiddy J. Paradoxical relationship between acetylator phenotype and amonafide toxicity. Clin Pharmacol Ther 50, 573-579 (1991).

41. Mick R, Ratain MJ. Modeling interpatient pharmacodynamic variability of etoposide. J Natl Cancer Inst 83, 1560-1564 (1991).

42. Vokes EE, Moormeier JA, Ratain MJ, Egorin MJ, Haraf DJ, Mick R, Weichselbaum RR. 5-fluorouracil, hydroxyurea, and escalating doses of continuous infusion cisplatin with concomitant radiotherapy: A clinical and pharmacologic study. Cancer Chemother Pharmacol 29, 178-184 (1992).

43. Miller CB, Platanias LC, Mills SR, Zahurak ML, Ratain MJ, Ettinger DS, Jones RJ. A phase I/II trial of erythropoietin in the treatment of cisplatin-associated anemia. J Natl Cancer Inst 84, 98-103 (1992).

44. Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M. Ethical issues in phase I oncology research: A comparison of investigators and IRB chairpersons. J Clin Oncol 10, 1810-1816 (1992).

45. Golomb HM, Ratain MJ, Mick R, Daly K. Interferon treatment for hairy cell leukemia; an update on a cohort of 69 patients treated from 1983-86. Leukemia 6,1177-1180 (1992).

46. Schilsky RL, Ratain MJ, Janisch L, Vogelzang NJ, Lucas VS, Ravitch J, Hohneker JA, Clendeninn NJ, Tuttle RL. Phase I clinical and pharmacologic study of 502U83 administered as a 24 hour continuous intravenous infusion. Cancer Chemother Pharmacol 31, 283-288 (1993).

47. Vokes EE, Ratain MJ, Mick R, McEvilly JM, Haraf D, Hamasaki V, Kozloff M, Weichselbaum RR, Panje WR, Wenig B, Berezin F. Cisplatin, 5-fluorouracil and leucovorin augmented by interferon alfa-2b in head and neck cancer: a clinical and pharmacologic analysis. J Clin Oncol 11, 360-368 (1993).

48. Mick R, Ratain MJ. Model-guided determination of maximal tolerated dose in phase I clinical trials: Evidence for increased precision. J Natl Cancer Inst 85, 217-223 (1993).

49. Ratain MJ, Priest E, Janisch L, Vogelzang NJ. Phase I study of subcutaneous recombinant interleukin-2 and interferon alfa-2a. Cancer 71, 2371-2376 (1993).

50. Schilsky RL, Janisch L, Berezin F, Mick R, Vogelzang NJ, Ratain MJ. Phase I clinical and pharmacological study of iododeoxyuridine and bleomycin in patients with advanced cancer. Cancer Res 53, 1293-1296 (1993).

51. Ratain MJ, Mick R, Berezin F, Janisch L, Schilsky RL, Vogelzang NJ, Lane LB. Phase I study of amonafide dosing based on acetylator phenotype. Cancer Res 53, 2304-2308 (1993).

52. Vokes EE, Dolan ME, Krishnasamy S, Mick R, Ratain MJ, Berezin F, Brachman D, Whitman G, Schilsky RL, Weichselbaum RR, Charette J, Dohrmann GJ, Hekmatpanah J. 5-fluorouracil, hydroxyurea and escalating doses of iododeoxyuridine with concomitant radiotherapy for malignant gliomas: a clinical and pharmacologic analysis. Ann Oncol 4, 591-595 (1993).

53. Vokes EE, O'Brien S, Vogelzang NJ, Schilsky RL, Ratain MJ. Five day infusional fluorodeoxyuridine with oral leucovorin and escalating doses of interferon alfa-2b: a phase I study. Cancer Chemother Pharmacol 32, 347-352 (1993).

54. Mick R, Ratain MJ. Statistical approaches to pharmacodynamic modeling: motivations, methods and misperceptions. Cancer Chemother Pharmacol 33,1-9 (1993).

55. Lichtman SM, Ratain MJ, Van Echo DA, Rosner G, Egorin MJ, Budman DR, Norton L, Vogelzang NJ, Schilsky RL. Phase I trial of granulocyte-macrophage colony stimulating factor plus high-dose cyclophosphamide given every 2 weeks: a Cancer and Leukemia Group B study. J Natl Cancer Inst 85, 1319-1326 (1993).

56. Samuels BL, Mick R, Vogelzang NJ, Williams SF, Schilsky RL, Safa AR, O'Brien S, Ratain MJ. Modulation of vinblastine resistance with cyclosporine A: a phase I study. Clin Pharmacol Ther 54, 421-429 (1993).

57. Ratain MJ, Mick R, Schilsky RL, Siegler M. Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 85, 1637-1643 (1993).

58. Vogelzang NJ, Mick R, Janisch L, Berezin F, Schilsky RL, Ratain MJ. A phase I and pharmacokinetic study of a new antineoplastic agent: pyrazine diazohydroxide (NSC 361456). Cancer Res 54, 114-119 (1994).

59. Devine SM, Ratain MJ, Janisch L, Richards JM, Williams SF, Schilsky RL, Vogelzang NJ, Skosey C. Phase I trial of thiotepa, granulocyte-macrophage colony stimulating factor and prednisone or pentoxifylline in patients with refractory solid tumors. Oncol Rep 1, 213-216 (1994).

60. Platanias LC, Ratain MJ, O'Brien S, Larson RA, Vardiman JW, Shaw JP, Williams SF, Baron JM, Parker K, Woodworth TG. Phase I trial of a genetically engineered interleukin-2 fusion toxin (DAB486 IL-2) as a 6 hour intravenous infusion in patients with hematologic malignancies. Leukemia Lymphoma 14, 257-262 (1994).

61. Fleming GF, Ratain MJ, O'Brien SM, Schilsky RL, Hoffman PC, Richards JM, Vogelzang NJ, Kasunic DA, Earhart RH. Phase I study of adozelesin administered by 24-hour continuous intravenous infusion. J Natl Cancer Inst 86, 368-372 (1994).

62. Mick R, Ratain MJ. Bootstrap validation of pharmacodynamic models defined by way of stepwise linear regression. Clin Pharmacol Ther 56, 217-222 (1994).

63. Kobayashi K, Vogelzang NJ, O'Brien SM, Schilsky RL, Vokes EE, Ratain MJ. A phase I study of intermittent infusion cladribine in patients with solid tumors. Cancer 74, 168-173 (1994).

64. Mitchell RB, Dolan ME, Janisch L, Vogelzang NJ, Ratain MJ, Schilsky RL. Sequential therapy with dacarbazine and carmustine: A phase I study. Cancer Chemother Pharmacol 34, 509-514 (1994).

65. Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ. Metabolic fate of irinotecan (CPT-11) in humans: correlation of glucuronidation with diarrhea. Cancer Res 54, 3723-3725 (1994).

66. Janisch L, Mick R, Schilsky RL, Vogelzang NJ, O'Brien S, Kut M, Ratain MJ. Prognostic factors for survival in patients treated on phase I clinical trials. Cancer 74, 1965-1973 (1994).

67. Mick R, Lane N, Daugherty C, Ratain MJ. Physician-determined patient risk of toxicity: impact on enrollment and decision making in phase I cancer trials. J Natl Cancer Inst 86, 1685-1693 (1994).

68. Karlsson MO, Port RE, Ratain MJ, Sheiner LB. A population model for the leukopenic effect of etoposide. Clin Pharmacol Ther 57, 325-334 (1995).

69. Ratain MJ, Rosner G, Allen SL, Costanza ME, Van Echo DA, Henderson IC, Schilsky RL. Population pharmacodynamic study of amonafide: A Cancer and Leukemia Group B study. J Clin Oncol 13, 741-747 (1995).

70. Larson RA, Geller RB, Janisch L, Suarez D, Milton J, Grochow LB, Ratain MJ. Encephalopathy is the dose-limiting toxicity of intravenous hepsulfam: results of a phase I trial in patients with advanced hematological malignancies. Cancer Chemother Pharmacol 36, 204-210 (1995).

71. Daugherty C, Ratain MJ, Grochowski E, Stocking C, Kodish E, Mick R, Siegler M. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13, 1062-1072 (1995).

72. Costanza ME, Berry D, Henderson IC, Ratain MJ, Wu K, Shapiro C, Duggan D, Kalra J, Berkowitz I, Lyss AP. Amonafide: an active agent in the treatment of previously untreated advanced breast cancer: a Cancer and Leukemia Group B study (CALGB 8642). Clin Cancer Res 1, 699-704 (1995).

73. Lilenbaum RC, Ratain MJ, Miller AA, Hargis JB, Hollis DR, Rosner GL, O'Brien SM, Brewster L, Graham L, Green MR, Schilsky RL. Phase I study of paclitaxel and topotecan in patients with advanced tumors: a Cancer and Leukemia Group B study. J Clin Oncol 13, 2230-2237 (1995).

74. Kobayashi K, Vokes EE, Vogelzang NJ, Janisch L, Soliven B, Ratain MJ. A phase I study of suramin (NSC 34936) given by intermittent infusion without adaptive control in patients with advanced cancer. J Clin Oncol 13, 2196-2207 (1995).

75. Gupta E, Olopade OI, Ratain MJ, Mick R, Berezin FK, Benson AB, Dolan ME. Pharmacokinetics and pharmacodynamics of oltipraz as a chemopreventive agent. Clin Cancer Res 1, 1133-1138 (1995).

76. Kobayashi K, Pezen DS, Vogelzang NJ, Medenica M, Janisch L, Ratain M, Vokes EE, Soltani K. Keratoacanthomas and skin neoplasms associated with suramin. Arch Dermatol 132, 96-98 (1996).

77. Ratain MJ, Mick R, Janisch L, Berezin F, Schilsky RL, Vogelzang NJ, Kut M. Individualized dosing of amonafide based on a pharmacodynamic model incorporating acetylator phenotype and gender. Pharmacogenetics 6, 93-101 (1996).

78. Larson RA, Mick R, Spielberger RT, O'Brien SM, Ratain MJ. A dose escalation trial of cladribine using five daily intravenous infusions in patients with advanced hematologic malignancies. J Clin Oncol 14, 188-195 (1996).

79. Minami H, Beijnen JH, Verweij J, Ratain MJ. Limited sampling model for area under the concentration-time curve of total topotecan. Clin Cancer Res 2, 43-46 (1996).

80. Mick R, Vokes EE, Lestingi TM, Gray-Stern W, Fleming GF, Schilsky RL, Ratain MJ. Etoposide combined with interferon alfa-2b: novel exploitation of established etoposide pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 59, 349-359 (1996).

81. Vokes EE, Mick R, Kies M, Dolan ME, Malone D, Athanasiadis I, Haraf DJ, Kozloff M, Weichselbaum RR, Ratain MJ. Pharmacodynamics of fluorouracil-based induction chemotherapy in advanced head and neck cancer. J Clin Oncol 14,1663-1671 (1996).

82. Gupta E, Safa AR, Wang X, Ratain MJ. Pharmacokinetic modulation of irinotecan and metabolites by cyclosporine A. Cancer Res 56, 1309-1314 (1996).

83. Mick R, Gupta E, Vokes EE, Ratain MJ. Limited sampling models for irinotecan (CPT-11) pharmacokinetics-pharmacodynamics: prediction of biliary index and intestinal toxicity. J Clin Oncol 14, 2012-2019 (1996).

84. Fleming GF, Janisch L, Vogelzang NJ, Vokes EE, Ratain MJ. Phase I study of escalating doses of mitoxantrone and paclitaxel with granulocyte-macrophage colony stimulating factor support. Cancer 77, 2308-2312 (1996).

85. Kobayashi K, Weiss RE, Vogelzang NJ, Vokes EE, Janisch L, Ratain MJ. Mineralocorticoid insufficiency due to suramin therapy. Cancer 78, 2411-2420 (1996).

86. Minami H, Ratain MJ, Ando Y, Shimokata K. Pharmacodynamic modeling of prolonged administration of etoposide. Cancer Chemother Pharmacol 39, 61-66 (1996).

87. Fleming GF, O'Brien SM, Hoffman PC, Vokes EE, Vogelzang NJ, Schilsky RL, Waggoner SE, Ratain MJ. Phase I study of treatment with oral 13-cisretinoic acid, subcutaneous interferon alfa-2a, cisplatin, and 24-hour infusion 5-fluorouracil/leucovorin. Cancer Chemother Pharmacol 39, 227-232 (1997).

88. Ramirez J, Ogan K, Ratain MJ. Determination of vinca alkaloids in human plasma by liquid chromatography/atmospheric pressure chemical ionization mass spectrometry. Cancer Chemother Pharmacol 39, 286-290 (1997).

89. Soliven B, Dhand UK, Kobayashi K, Arora R, Martin B, Petersen M, Janisch L, Vogelzang NJ, Vokes EE, Ratain MJ. Evaluation of neuropathy in patients on suramin treatment. Muscle Nerve 20, 83-91 (1997).

90. Gupta E, Wang X, Ramirez J, Ratain MJ. Modulation of glucuronidation of SN-38, the active metabolite of irinotecan, by valproic acid and phenobarbital. Cancer Chemother Pharmacol 39, 440-444 (1997).

91. Gupta E, Mick R, Ramirez J, Wang X, Lestingi TM, Vokes EE, Ratain MJ. A pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan (CPT-11) in cancer patients. J Clin Oncol 15, 1502-1510 (1997).

92. Johnston PG, Mick R, Recant W, Behan KA, Dolan ME, Ratain MJ, Beckmann E, Weichselbaum RR, Allegra CJ, Vokes EE. Thymidylate synthase expression predicts for response to neoadjuvant induction chemotherapy in advanced head and neck cancer. J Natl Cancer Inst 89, 308-313 (1997).

93. Miller AA, Rosner GL, Ratain MJ, Hollis DR, Green MR, Schilsky RL. Pharmacology of 21-day oral etoposide given in combination with intravenous cisplatin in patients with extensive-stage small-cell lung cancer: a Cancer and Leukemia Group B Study (CALGB 9062). Clin Cancer Res 3, 719-725 (1997).

94. Daugherty CK, Siegler M, Ratain MJ, Zimmer GD. Learning from our patients: one subjects impact on clinical research. Ann Intern Med 125, 892-897 (1997).

95. Boddy AV, Ratain MJ. Pharmacogenetics in cancer etiology and chemotherapy. Clin Cancer Res 3, 1025-1030 (1997).

96. Ratain MJ, Skoog LA, OBrien SM, Cooper N, Schilsky RL, Vogelzang NJ, Gerber M, Narang PK, Nicol SJ. Phase I study of 3'-deamino-3'-(2-methoxy-4-morpholinyl) doxorubicin (FCE 23762, PNU 152243) administered on a daily x 3 schedule. Ann Oncol 8, 807-809 (1997).

97. LeMaistre CF, Saleh MN, Kuzel TM, Foss F, Platanias LC, Schwartz G, Ratain M, Rook A, Freytes CO, Craig F, Reuben J, Nichols JC. Phase I trial of a ligand fusion-protein (DAB389IL-2) in lymphomas expressing the receptor for interleukin-2. Blood 91, 399-405 (1998).

98. Mani S, Iyer L, Janisch L, Wang X, Fleming GF, Schilsky RL, Ratain MJ. Phase I clinical and pharmacokinetic study of oral 9-aminocamptothecin (NSC-603071). Cancer Chemother Pharmacol 42, 84-87 (1998).

99. Iyer L, King CD, Whitington PF, Green MD, Roy SK, Tephly TR, Ratain MJ. Genetic predisposition to the metabolism of irinotecan (CPT-11): role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomes. J Clin Invest 101, 847-854 (1998).

100. Rini BI, Stadler WM, Spielberger RT, Ratain MJ, Vogelzang NJ. Granulocyte-macrophage colony-stimulating factor (GM-CSF) in metastatic renal cell cancer: a phase II trial. Cancer 82, 1352-1358 (1998).

101. Brockstein B, Haraf DJ, Stenson K, Fasanmade A, Stupp R, Glisson B, Lippman SM, Ratain MJ, Sulzen L, Klepsch A, Weichselbaum RR, Vokes EE. Phase I study of concomitant chemoradiotherapy with paclitaxel, fluorouracil, and hydroxyurea with granulocyte colony stimulating factor support for patients with poor-prognosis cancer of the head and neck. J Clin Oncol 16, 735-744 (1998).

102. Schilsky RL, Hohneker J, Ratain MJ, Janisch L, Smetzler L, Lucas VS, Khor SP, Diasio R, Von Hoff DD, Burris HA. Phase I clinical and pharmacologic study of eniluracil plus fluorouracil in patients with advanced cancer. J Clin Oncol 16, 1450-1457 (1998).

103. Venook AP, Egorin MJ, Rosner GL, Brown TD, Jahan TM, Batist G, Hohl R, Budman DR, Ratain MJ, Kearns CM, Schilsky RL. Phase I and pharmacokinetic trial of paclitaxel in patients with hepatic dysfunction: Cancer and Leukemia Group B 9264. J Clin Oncol 16, 1811-1819 (1998).

104. Vogelzang NJ, Mani S, Schilsky RL, Ansari RH, Taber D, Rhinehart SN, Garcia JC, Meyer SC, Mick R, Brockstein BE, Stadler WM, Ratain MJ, Vokes EE. Phase II and pharmacodynamic studies of pyrazine diazohydroxide (NSC 361456) in advanced renal and colorectal cancer. Clin Cancer Res 4, 929-934 (1998).

105. Dolan ME, Roy SK, Fasanmade AA, Paras PR, Schilsky RL, Ratain MJ. O6-benzylguanine in humans: metabolic, pharmacokinetic and pharmacodynamic findings. J Clin Oncol 16, 1803-1810 (1998).

106. Fleming GF, Kugler JW, Hoffman PC, Ansari R, Bitran JD, Klepsch A, Malone D, Fasanmade AA, Ratain MJ, Vokes EE. Phase II trial of paclitaxel and topotecan with granulocyte-colony stimulating factor support in stage IV breast cancer. J Clin Oncol 16, 2032-2037 (1998).

107. DeMario MD, Ratain MJ. Oral chemotherapy: rationale and future directions. J Clin Oncol 16, 2557-2567 (1998).

108. Daugherty CK, Ratain MJ, Minami H, Banik DM, Vogelzang NJ, Stadler WM, Siegler M. Study of cohort-specific consent and patient control in phase I cancer trials. J Clin Oncol 16, 2305-2312 (1998).

109. Budman DR, Rosner G, Lichtman S, Miller A, Ratain MJ, Schilsky RL. A randomized trial of amifostine as a chemoprotective agent in combination with cyclophosphamide and molgramostim (GM-CSF). Cancer Ther 1, 164-167 (1998).

110. Vokes EE, Janisch L, Spector B, Lestingi T, Gupta E, Schilsky RL, Ratain MJ. A phase I dose-intensification study of irinotecan (CPT-11) with maximized supportive care. Cancer Ther 1, 223-228 (1998).

111. Lilenbaum RC, Miller AA, Batist G, Bernard S, Hollis DR, Rosner GL, Egorin MJ, Schilsky RL, Ratain MJ. Phase I and pharmacologic study of continuous infusion topotecan in combination with cisplatin in patients with advanced cancer: a Cancer and Leukemia Group B Study. J Clin Oncol 16, 3302-3309 (1998).

112. Vokes EE, Ansari RH, Masters GA, Hoffman PC, Klepsch A, Ratain MJ, Sciortino DF, Lad TE, Krauss S, Fishkin PAS, Golomb HM. A phase II study of 9-aminocamptothecin in advanced non-small-cell lung cancer. Ann Oncol 9, 1085-1090 (1998).

113. Saleh MN, LeMaistre CF, Kuzel TM, Foss F, Platanias LC, Schwartz G, Ratain M, Rook A, Freytes CO, Craig F, Reuben J, Sams MW, Nichols JC. Antitumor activity of DAB389IL-2 fusion toxin in mycosis fungoides. J Am Acad Dermatol 39, 63-73 (1998).

114. House LK, Ramirez J, Ratain MJ. Simultaneous determination of 5-fluorouracil and uracil by high performance liquid chromatography using four serial columns. J Chromatogr B 720, 245-250 (1998).

115. Iyer L, Ratain MJ. 5-fluorouracil (5-FU) pharmacokinetics: Causes for variability and strategies for modulation in cancer chemotherapy. Cancer Invest 17, 494-506 (1999).

116. De Mario MD, Ratain MJ, Vogelzang NJ, Mani S, Vokes EE, Fleming GF, Melton K, Johnson S, Benner S, Lebwohl D. A phase I study of oral uracil/ftorafur (UFT) plus leucovorin and bis-acetato-ammine-dichloro-cyclohexylamine-platinum IV (JM-216) each given over 14 days every 28 days. Cancer Chemother Pharmacol 43, 385-388 (1999).

117. Humerickhouse RA, Dolan ME, Haraf DJ, Brockstein B, Stenson K, Kies M, Sulzen L, Ratain MJ, Vokes EE. Phase I study of eniluracil, a dihydropyrimidine dehydrogenase inactivator, and oral 5-fluorouracil with radiation therapy in patients with recurrent or advanced head and neck cancer. Clin Cancer Res 5, 291-298 (1999).

118. Vokes EE, Goh BC, Bertucci D, Vogelzang NJ, Mani S, Ratain MJ. A phase I study of raltitrexed and paclitaxel as three weekly schedule in patients with solid tumors. Cancer 86, 528-532 (1999).

119. Iyer L, Hall D, Das S, Mortell MA, Ramirez J, Kim S, DiRienzo A, Ratain MJ. Phenotype/genotype correlation of in vitro SN-38 (active metabolite of irinotecan) and bilirubin glucuronidation in human liver tissue with UGT1A1 promoter polymorphism. Clin Pharmacol Ther 65, 576-582 (1999).

120. Minami H, Lad T, Nicholas MK, Vokes EE, Ratain MJ. Pharmacokinetics and pharmacodynamics of 9-aminocamptothecin infused over 72 hours in phase II studies. Clin Cancer Res 5, 1325-1330 (1999).

121. Gelmon KA, Eisenhauer EA, Harris AL, Ratain MJ, Workman P. Anticancer agents targeting signaling molecules and cancer cell environment: Challenges for drug development? J Natl Cancer Inst 91, 1281-1287 (1999).

122. Brockstein BE, Shepard DR, Kugler JW, Fishkin PA, Arrieta R, Ratain MJ, Vokes EE, Vogelzang NJ. A phase II trial of oral trimethylcolchicinic acid in patients with hormone refractory prostate cancer. Prostate J 1, 195-202 (1999).

123. Stadler WM, Ratain MJ. Development of target-based antineoplastic agents. Invest New Drugs 18, 7-16 (2000).

124. Daugherty CK, Banik DM, Janisch L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview study of 144 advanced cancer patients. IRB Rev Hum Sub Res 22, 6-14 (2000).

125. Goh BC, Fleming GF, Janisch L, Vogelzang NJ, Stadler WM, Ratain MJ. Development of a schedule-dependent population pharmacodynamic model for rhizoxin without quantitation of plasma concentrations. Cancer Chemother Pharmacol 45, 489-494 (2000)

126. Kastrissios H, Ratain MJ. Screening for sources of interindividual pharmacokinetic variability in anticancer drug therapy: utility of population analysis. Cancer Invest, in press (2000).

127. Ryan CW, Fleming GF, Janisch L, Ratain MJ. A phase I study of liposomal doxorubicin (DOXILÒ ) with topotecan. Am J Clin Oncol 23, 297-300 (2000).

128. Schilsky RL, Dolan ME, Ewesuedo RB, Bertucci D, Vogelzang NJ, Mani S, Wilson LR, Ratain MJ. Phase I clinical and pharmacological study of O6-benzylguanine followed by carmustine in patients with advanced cancer. Clin Cancer Res 6, 3025-3031 (2000).

129. Venook AP, Egorin MJ, Rosner GL, Hollis D, Mani S, Hawkins M, Byrd J, Hohl R, Budman D, Meropol N, Ratain MJ. A phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: CALGB 9565. J Clin Oncol 18, 2780-2787 (2000).

130. Innocenti F, Stadler WM, Iyer L, Ramierez J, Vokes EE, Ratain MJ. Flavopiridol metabolism in cancer patients is associated with the occurrence of diarrhea. Clin Cancer Res 6, 3400-3405 (2000).

131. Benson AB, Olopade OI, Ratain MJ, Rademaker A, Mobarhan S, Stucky-Marshall L, French S, Dolan ME. Chronic daily low dose of 4-methyl-5 (2-pyrazinyl)-1,2 dithiole-3-thione (oltipraz) in patients with previously resected colon polyps and first degree female relatives of breast cancer patients. Clin Cancer Res 6, 3870-3877 (2000).

132. Innocenti F, Iyer L, Ratain MJ. Pharmacogenetics: A tool for individualizing antineoplastic therapy. Clin Pharmacokin 39, 315-325 (2000)

133. Joshi AS, Vokes EE, Pieniaszek HJ, Vogelzang NJ, Davidson AF, Richards LE, Chai MF, Finzio M, Ratain MJ. Disposition of [14C] losoxantrone in four cancer patients. Drug Metab Disp, in press (2001).

134. Innocenti F, Iyer L, Ratain MJ. Pharmacogenetics of anti-cancer agents: lessons from amonafide and irinotecan. Drug Metab Disp, in press (2001).

135. Goh BC, Ratain MJ, Bertucci D, Smith R, Mani S, Vogelzang NJ, Schilsky RL, Hutchison M, Smith M, Averbuch S, Douglass E. Phase I study of ZD9331 on short daily intravenous bolus infusion x5 days every 3 weeks with fixed dosing recommendations. J Clin Oncol, in press (2001).

136. Ewesuedo RB, Iyer L, Das S, Koenig A, Mani S, Vogelzang NJ, Schilsky RL, Brenckman W, Ratain MJ. Phase I clinical and pharmacogenetic study of weekly TAS-103 in patients with advanced cancer. J Clin Oncol, in press (2001).

137. Rudin CM, Holmlund J, Fleming GF, Mani S, Stadler WM, Dorr FA, Ratain MJ. A phase I trial of ISIS 5132, an antisense oligonucleotide inhibitor of c-Raf-1, administered by 24-hour weekly infusion to patients with advanced cancer. Clin Cancer Res, in press (2001).

138. Innocenti F, Iyer L, Ramirez J, Green MD, Ratain MJ. Epirubicin glucuronidation is catalyzed by human UDP-glucuronosyltransferase 2B7 (UGT2B7). Drug Metab Disp, in press (2001).


Other Articles and Book Chapters

1. Golomb HM, Ratain MJ. Use in hairy cell leukemia. An update. In: Interferon Alpha-2: Pre-Clinical and Clinical Evaluation (eds. D.L. Kisner and J.F. Smyth), Martinus Nijhoff, Boston, pp. 87-92 (1985).

2. Golomb HM, Ratain MJ, Westbrook C, Daly K. The treatment of hairy cell leukemia. In: Leukemia: Recent Advances in Biology and Treatment (eds. R.P. Gale and D.W. Golde), Alan R. Liss, New York, pp 715-724 (1985).

3. Golomb HM, Ratain MJ, Vardiman JW. Sequential treatment of hairy cell leukemia; a new role for interferon. In: Important Advances in Oncology 1986 (eds. V.T. DeVita, Jr., S. Hellman and S.A. Rosenberg), J.B. Lippincott Company, Philadelphia, pp 311-321 (1986).

4. Ratain MJ, Vardiman JW, Golomb HM. The role of interferon in the treatment of hairy cell leukemia. Semin Oncol 13 (Suppl 2), 21-28 (1986).

5. Ratain MJ, Vogelzang NJ. Experimental rationale for continuous infusion chemotherapy. In: Cancer Chemotherapy by Infusion (ed. J.J. Lokich), Precept Press, Chicago, pp 12-34 (1987).

6. Ratain MJ, Vogelzang NJ, Bodey GP. Periwinkle alkaloids I: Vinblastine and vindesine. In: Cancer Chemotherapy by Infusion (ed. J.J. Lokich), Precept Press, Chicago, pp 167-180 (1987).

7. Bardawil RG, Ratain MJ, Golomb HM, Bitter MA, Groves C, Vardiman JW. Changes in peripheral blood and bone marrow specimens during and after interferon alfa-2b therapy for hairy cell leukemia. Leukemia 1, 340-343 (1987).

8. Golomb HM, Fefer A, Golde DW, Ozer H, Portlock C, Silber R, Rappeport J, Ratain MJ, Thompson J, Bonnem EM, Spiegel RJ, Tensen L, Burke JS, Vardiman JW. Sequential evaluation of alpha-2-interferon treatment in 128 patients with hairy cell leukemia. Semin Oncol 14 (Suppl 2), 13-17 (1987).

9. Egorin MJ, Cohen BE, Herzig RH, Ratain MJ, Peters WP. Human plasma pharmacokinetics and urinary excretion of thiotepa and its metabolites in patients receiving high-dose thiotepa therapy. In: High-Dose Thiotepa and Autologous Marrow Transplantation (ed. G.P. Herzig), John Wiley and Sons, New York, pp. 3-8 (1987).

10. Golomb HM, Ratain MJ. Recent advances in the treatment of hairy cell leukemia. N Engl J Med 316, 870-872 (1987).

11. Golomb HM, Fefer A, Golde DW, Ozer H, Portlock C, Silber R, Rappeport J, Ratain MJ, Thompson J, Bonnem E, Spiegel R, Tensen L, Burke JS, Vardiman JW. Report of a multi-institutional study of 193 patients with hairy cell leukemia treated with interferon-alfa-2b. Semin Oncol 15 (Suppl 5), 7-9 (1988).

12. Golomb HM, Ratain MJ, Moormeier J. What is the choice of treatment for hairy cell leukemia? J Clin Oncol 7, 156-158 (1989).

13. Doane L, Ratain MJ, Golomb HM. Hairy cell leukemia: Current management. Hematol Oncol Clin N Amer 4, 489-502 (1990).

14. Mitchell RB, Ratain MJ, Vogelzang NJ. Experimental rationale for continuous infusion chemotherapy. In: Cancer Chemotherapy by Infusion, Second Edition (ed. J.J. Lokich), Precept Press, Chicago, pp. 3-34 (1990)

15. Ratain MJ. Monitoring plasma concentrations of clinically useful antineoplastics during continuous infusion chemotherapy. In: Cancer Chemotherapy by Infusion, Second Edition (ed. J.J. Lokich), Precept Press, Chicago, pp. 647-652 (1990).

16. Ratain MJ, Golomb HM. Hairy cell leukemia. In: Comprehensive Textbook of Oncology, Second Edition (eds. A.R. Moosa, S.C. Schimpff, and M.C. Robson), Williams & Wilkins, Baltimore, pp. 1225-1231 (1991).

17. Mitchell RB, Ratain MJ, Vogelzang NJ. Experimental rationale for continuous infusion chemotherapy. In: Concomitant Continuous Infusion Chemotherapy and Radiation (eds. M. Rotman and C. J. Rosenthal), Springer-Verlag, Berlin, pp. 13-27 (1991).

18. Platanias LC, Ratain MJ. Hairy cell leukaemia: The role of alpha interferon. Eur J Cancer 27 (Suppl 4), S53-S57 (1991).

19. Platanias LC, Ratain MJ. Hairy-cell leukemia. In: Current Therapy in Hematology/Oncology, Fourth Edition (eds. M.C. Brain and P.P. Carbone), B. C. Decker, Philadelphia, pp. 73-79 (1992).

20. Ratain MJ, Schilsky RL. Principles of pharmacology and pharmacokinetics. In: The Chemotherapy Source Book (ed. M.C. Perry), Williams & Wilkins, Baltimore, pp. 22-35 (1992).

21. Ratain MJ, Rowley JD. Therapy-related acute myeloid leukemia secondary to inhibitors of topoisomerase II: From the bedside to the target genes. Ann Oncol 3, 107-111 (1992).

22. Kobayashi K, Ratain MJ. New perspectives on the toxicity of etoposide. Semin Oncol 19 (6 Suppl 13), 78-83 (1992).

23. Ratain MJ. Important aspects of pharmacodynamics and pharmacogenetics: considerations for use of cytotoxics. In: American Society of Clinical Oncology Educational Book, American Society of Clinical Oncology, Chicago, pp. 92-96 (1992).

24. Golomb HM, Ratain MJ, Mick R, Daly K. The treatment of hairy cell leukemia: an update. Leukemia 6 (Suppl 2), 24-27 (1992).

25. Schilsky RL, Ratain MJ, Vokes EE, Vogelzang NJ, Anderson J, Peterson BA. Laboratory and clinical studies of biochemical modulation by hydroxyurea. Semin Oncol 19 (3 Suppl 9), 84-89 (1992).

26. Ratain MJ. Therapeutic relevance of pharmacokinetics and pharmacodynamics. Semin Oncol 19 (4 Suppl 11), 8-13 (1992).

27. Kobayashi K, Ratain MJ. General principles of pharmacokinetics and pharmacodynamics: infusional chemotherapy. J Infus Chemo 2, 158-159 (1992).

28. Ratain MJ. Guest editorial. J Infus Chemo 2, 157 (1992).

29. Platanias LC, Ratain MJ. Use of r-HuEPO in the treatment of the anaemia of cancer. Erythropoiesis 3, 107-110 (1992).

30. Ratain MJ, Schilsky RL. Pharmacology. In: Cancer Medicine, Third Edition (eds. J.F. Holland, E. Frei, R.C. Bast, et al.), Lea & Febiger, Philadelphia, pp. 671-683 (1993).

31. Kobayashi K, Ratain MJ. Individualized dosing of cancer chemotherapy. Semin Oncol 20, 30-42 (1993).

32. Kobayashi K, Jodrell DI, Ratain MJ. Pharmacodynamic-pharmacokinetic relationships and therapeutic drug monitoring. Cancer Surv 17, 51-78 (1993).

33. Rosner GL, Ratain MJ. Pharmacodynamics of antineoplastic agents. In: Pharmacodynamics and Drug Development: Perspectives in Clinical Pharmacology (eds. N.R. Cutler, J.J. Sramek, P.K. Narang), Wiley, Chichester, pp. 345-362 (1994).

34. Kobayashi K, Ratain MJ. Pharmacodynamics and long-term toxicity of etoposide. Cancer Chemother Pharmacol 34 (Suppl), S64-S68 (1994).

35. Spielberger RT, Mick R, Ratain MJ, Golomb HM. Interferon treatment for hairy cell leukemia: an update on a cohort of 69 patients treated from 1983-86. Leukemia Lymphoma 14 (Suppl 1), 89-94 (1994).

36. Daugherty CK, Ratain MJ, Siegler M. Pushing the envelope: informed consent in phase I trials. Ann Oncol 6, 321-323 (1995).

37. Miller AA, Ratain MJ, Schilsky RL. Principles of pharmacology. In: The Chemotherapy Source Book, Second Edition (ed. M.C. Perry), Williams & Wilkins, Baltimore, pp. 27-41 (1996).

38. Ratain MJ, Mick R. Principles of pharmacokinetics and pharmacodynamics. In: Principles of Antineoplastic Drug Development and Pharmacology (eds. R.L. Schilsky, G.A. Milano, M.J. Ratain), Marcel Dekker, Inc., New York, pp. 123-141 (1996).

39. Mani S, Ratain MJ. Promising new agents in oncologic treatment. Curr Opin Oncol 8, 525-534 (1996).

40. Mani S, Ratain MJ. New phase I trial methodology. Semin Oncol 24, 253-261 (1997).

41. Ratain MJ, Plunkett W. Pharmacology. In: Cancer Medicine, Fourth Edition (eds. J.F. Holland, E. Frei, R.C. Bast, et al), Williams & Wilkins, Baltimore, pp. 875-889, (1997).

42. Ratain MJ. Pharmacokinetics and pharmacodynamics. In: Principles and Practice of Oncology, Fifth Edition (eds. V.T. DeVita, S. Hellman, S.A. Rosenberg), Lippincott-Raven Publishers, Philadelphia, pp. 375-385 (1997).

43. Stewart CF, Ratain MJ. Topoisomerase inhibitors. In: Principles and Practice of Oncology, Fifth Edition (eds. V.T. DeVita, S. Hellman, S.A. Rosenberg), Lippincott-Raven Publishers, Philadelphia, pp. 452-467 (1997).

44. Daugherty CK, Ratain MJ, Siegler M. Ethical issues in clinical research of cancer. In: Principles and Practice of Oncology, Fifth Edition (eds. V.T. DeVita, S. Hellman, S.A. Rosenberg), Lippincott-Raven Publishers, Philadelphia, pp. 534-542 (1997).

45. Nichols J, Foss F, Kuzel TM, LeMaistre CF, Platanias L, Ratain MJ, Rook A, Saleh M, Schwartz G. Interleukin-2 fusion protein: a novel therapy for interleukin-2 receptor expressing malignancies. Eur J Cancer 33 (Suppl 1), S34 – S36 (1997)

46. American Society of Clinical Oncology. Critical role of phase I clinical trials in cancer treatment. J Clin Oncol 15, 853-859 (1997).

47. Gupta E, Ratain MJ. Camptothecin analogues: topotecan and irinotecan. In: A Clinicians Guide to Chemotherapy Pharmacokinetics and Pharmacodynamics (eds. L.B. Grochow, M. Ames), Williams & Wilkins, Baltimore, pp. 435-457 (1998).

48. DeMario MD, Ratain MJ. Rationale for phase I study of UFT plus leucovorin and oral JM-216. Oncology 11 (Suppl 10), 26-29 (1997).

49. Ewesuedo RB, Ratain MJ. Topoisomerase I inhibitors. Oncologist 2, 359-364 (1997).

50. Iyer L, Ratain MJ. Clinical pharmacology of camptothecins. Cancer Chemother Pharmacol 42 (Suppl), S31-S43 (1998).

51. Iyer L, Ratain MJ. Pharmacogenetics and cancer chemotherapy. Eur J Cancer 34, 1493-1499 (1998).

52. Ratain MJ. New agents for colon cancer: topoisomerase I inhibitors. In: American Society of Clinical Oncology Educational Book (ed. M.C. Perry), American Society of Clinical Oncology, Alexandria, pp. 311-315 (1998).

53. Ratain MJ. Body surface area as a basis for dosing of anticancer agents: science, myth or habit? J Clin Oncol 16, 2297-2298 (1998).

54. Ratain MJ. Development of target-based antineoplastic agents. In: American Society of Clinical Oncology Educational Book (ed. M.C. Perry), American Society of Clinical Oncology, Alexandria, 71-75 (1999).

55. Ratain MJ, Ewesuedo RB. Cancer chemotherapy. In: Oncologic Therapies (eds. E.E. Vokes, H.M. Golomb), Springer, Berlin, pp. 36-118 (1999).

56. Ratain MJ. Drug combinations: dangerous liaisons or great expectations? Ann Oncol 10, 375-376 (1999).

57. Ratain MJ. Introduction. Classic Papers Current Comments 4, 1 (1999).

58. Ratain MJ. Author update: Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. Classic Papers Current Comments 4, 236-237 (1999).

59. Ratain MJ. Editor update: Plasma and tumor tissue pharmacology of high-dose intravenous leucovorin calcium in combination with fluorourail in patients with advanced colorectal carcinoma. Classic Papers Current Comments 4, 254 (1999).

60. Ratain MJ. Author update: Population pharmacodynamic study of amonafide: A Cancer and Leukemia Group B Study. Classic Papers Current Comments 4, 280 (1999).

61. Ratain MJ, Plunkett W. Pharmacology. In: Cancer Medicine e.5 (eds. R.C. Bast Jr., D.W. Kufe, R.E. Pollock, et al.), B.C. Decker, Hamilton, pp. 589-611 (2000).

62. Ratain MJ. Pharmacokinetics and pharmacodynamics. In: Principles and Practice of Oncology, Sixth Edition (eds. V.T. DeVita, S. Hellman, S.A. Rosenberg), Lippincott-Raven Publishers, Philadelphia, in press (2000).

63. Ratain MJ. Insights into the pharmacokinetics and pharmacodynamics of irinotecan. Clin Cancer Res 6, 3393-3394 (2000).

64. Stewart CF, Ratain MJ. Topoisomerase inhibitors. In: Principles and Practice of Oncology, Sixth Edition (eds. V.T. DeVita, S. Hellman, S.A. Rosenberg), Lippincott-Raven Publishers, Philadelphia, in press (2000).


Books

1. Schilsky RL, Milano GA, Ratain MJ. Principles of Antineoplastic Drug Development and Pharmacology, Marcel Dekker, Inc., New York (1996).

2. Ratain MJ, Tempero M, Skosey C. Outline of Oncology Therapeutics, W.B. Saunders, Philadelphia (2001).

 

Abstracts, Letters, and Book Reviews

  1. Golomb HM, Ratain MJ, Vokes EE, Jacobs R, Vardiman J, Daly K. Treatment of advanced hairy cell leukemia with recombinant alpha-2-interferon. The Second International Congress on Malignant Lymphoma (1984).

  2. Ratain MJ, Jacobs R, Vokes E, Vardiman J, Golomb HM. A phase II trial of recombinant alpha-2-interferon in advanced hairy cell leukemia. XX Congress of the International Society of Hematology (1984).

  3. Bardawil R, Groves C, Ratain MJ, Golomb HM, Vardiman JW. Changes in peripheral blood and bone marrow specimens following therapy with recombinant alpha-2-interferon for hairy cell leukemia. American Society for Clinical Pathologists (1984).

  4. Ratain MJ, Golomb HM, Vardiman JW, Daly K. Rapid responses in advanced hairy cell leukemia with recombinant alpha-2-interferon. Clin Res 32, 789A (1984).

  5. Ratain MJ, Golomb HM, Vardiman JW, Bardawil R, Daly K. Effective treatment of hairy cell leukemia with recombinant alpha-2- interferon in 20 patients. Blood 64 (Suppl 1), 172a (1984).

  6. Bennett CL, Ratain MJ, Golomb HM. Treatment of atypical mycobacterial infection in hairy cell leukemia. Blood 64 (Suppl 1), 161a (1984).

  7. Vogelzang NJ, Ratain MJ. Cancer chemotherapy and skin changes (Letter). Ann Intern Med 103, 303-304 (1985).

  8. Ratain MJ, Vogelzang NJ, Sinkule JA, Holt JA. Phase I pharmacokinetic and toxicity study of prolonged continuous infusion vinblastine using infusion pumps. Proc Am Assoc Cancer Res 26, 162 (1985).

  9. Golomb HM, Fefer A, Ratain MJ, Thompson J, Ozer H, Portlock C, Spiegel R, Brady J. Intron A, recombinant alpha-2-interferon, for the treatment of hairy cell leukemia. Proc Am Soc Clin Oncol 4, 225 (1985).

  10. Golomb HM, Vardiman JW, Ratain MJ, Daly K. Hairy cell leukemia. J Cell Biochem suppl 9A, 130 (1985).

  11. Ratain MJ, Vogelzang NJ, Sinkule JA. Prolonged infusion of vinblastine with analysis of steady-state drug levels. Clin Res 33, 854A (1985).

  12. Ratain MJ, Golomb HM, Westbrook C, Vardiman JW, Daly K. Effective therapy for advanced hairy cell leukemia with alpha-2-interferon: an update. Clin Res 33, 881A (1985).

  13. Bennett CL, Vogelzang NJ, Ratain MJ, Potkul LJ, Reich SJ. Severe toxicity during a phase I trial of vinblastine and recombinant gamma interferon. Clin Res 33, 852A (1985).

  14. Bennett CL, Ratain MJ, Larson RA, MacMahon H, Daly KM. Ventilation-perfusion scans may detect early invasive pulmonary aspergillosis. Clin Res 33, 852A (1985).

  15. Ratain MJ, Vardiman JW, Golomb HM, Westbrook C, Daly K. Peripheral blood and bone marrow changes after discontinuance of alpha-interferon therapy in patients with hairy cell leukemia. Blood 66 (Suppl 1), 207a (1985).

  16. Ratain MJ, Golomb HM, Vardiman JW, Westbrook C, Daly K. Prolonged treatment of advanced hairy cell leukemia with recombinant alpha-2 interferon: assessment of prognostic variables. Blood 66 (Suppl 1), 207a (1985).

  17. Lembersky BC, Ratain MJ, Bennett CL, Golomb HM, Vardiman J. Osseous complications in hairy cell leukemia. Blood 66 (Suppl 1), 178a, (1985).

  18. Kaminer LS, Ratain MJ, Golomb HM, Vardiman J. A comparison of the presentation and clinical courses of hairy cell leukemia in men and women. Blood 66 (Suppl 1), 177a (1985).

  19. Berestka J, Roemeling R, Ganzer PJ, Ratain MJ, Wick M, Fraley E, Buchwald H, Langevin TR, Mushiya T, Hrushevsky WJM. Circadian dependency of vinblastine toxicity. The Second International Conference on Chronopharmacology (1986).

  20. Vokes EE, Bitter MA, Ratain MJ, Prystowsky MB, Daly K, Golomb HM. Flow cytometric evidence for increasing natural killer cell activity in patients with hairy cell leukemia treated with alpha-2-interferon. Proc Am Assoc Cancer Res 27, 153 (1986).

  21. Ratain MJ, Bitran JD, Larson RA, Golomb HM, Skosey C, Purl S, Hoffman PC, LeBeau MM, Wade J, Vardiman JW, Daly K. Increased risk of acute non-lymphocytic leukemia following cisplatin, etoposide, vindesine therapy for advanced non-small cell lung cancer. Proc Am Assoc Cancer Res 27, 153 (1986).

  22. Ratain MJ, Golomb H, Vardiman J, Westbrook C, Lembersky B, Kaminer L,Daly K. Durability of responses to alpha-2-interferon in advanced hairy cell leukemia. Proc Am Soc Clin Oncol 5, 163 (1986).

  23. Bennett C, Vogelzang N, Ratain MJ, Potkul L, Reich S. Severe toxicity during a phase I trial of vinblastine and recombinant gamma interferon. Proc Am Soc Clin Oncol 5, 233 (1986).

  24. Williams S, Bitran J, Ratain MJ, Egorin M, Sinkule J, Jacobs R, Beschorner J, Schroeder C, Purl S, Royston K. A phase I-II study of bialkylator chemotherapy with high-dose thiotepa and Cytoxan and autologous bone marrow infusion in patients with refractory lymphoma and disseminated carcinoma. Proc Am Soc Clin Oncol 5, 141 (1986).

  25. Ratain MJ, Schilsky RL. Correspondence re: M.J. Egorin et al. Human pharmacokinetics, excretion and metabolism of the anthracycline antibiotic menogaril (7-OMEN, NSC 269148) and their correlation with clinical toxicities (Letter). Cancer Res 46, 4874 (1986).

  26. Vogelzang NJ, Ruane M, Ratain MJ, Dhowlatshahi K, Chodak GW. Complications of an implanted pumping system for systemic chemotherapy. Clin Res 34, 934A (1986).

  27. Ackland SP, Choi KE, Ratain MJ, Sinkule JA, Williams SF, Bitran JD. Human pharmacokinetics of thiotepa following high dose administration. Clin Res 34, 930A (1986).

  28. Ratain MJ, Golomb HM, Vardiman JW, Westbrook CA, Lembersky BC, Daly K. Duration of response of hairy cell leukemia after treatment with interferon alfa-2b. Blood 68 (Suppl 1), 229a (1986).

  29. Ratain MJ, Vardiman JW, Golomb HM. Prognostic variables in hairy cell leukemia following splenectomy as initial therapy. Blood 68 (Suppl 1), 205a (1986).

  30. Bardawil R, Ratain MJ, Golomb HM, Groves C, Vardiman J. The neutrophil alkaline phosphatase scores reflect bone marrow changes in hairy cell leukemia during treatment with alfa-2b-interferon. Blood 68 (Suppl 1), 217a (1986).

  31. Ratain MJ, Vogelzang NJ. A predictive model for vinblastine pharmacokinetics using limited sampling. Clin Pharmacol Ther 41, 161 (1987).

  32. Ackland S, Choi K, Ratain MJ, Sinkule J, Egorin M, Williams S, Bitran J. Pharmacokinetics of thiotepa following high dose administration. Clin Pharmacol Ther 41, 170 (1987).

  33. Ratain MJ, Golomb HM, Vardiman JW, Westbrook CA, Lembersky BC, Daly K. Relapse of patients with hairy cell leukemia after response to interferon alfa-2b therapy. Proc Am Soc Clin Oncol 6, 165 (1987).

  34. Ratain MJ, Novotney-Barry A, Safa A, Schilsky RL. Comparative cellular pharmacokinetics of the vinca alkaloids. Proc Am Assoc Cancer Res 28, 335 (1987).

  35. Ratain MJ, Golomb HM, Vardiman JW. Durability of responses to interferon alfa-2b in advanced hairy cell leukemia. Fourth International Symposium on Therapy of Acute Leukemia (1987).

  36. Choi K, Ratain MJ, Williams S, Golick J, Beschorner J, Fullem L, Bitran J. Pharmacokinetic study of high-dose oral melphalan. Clin Res 35, 863A (1987).

  37. Wernli M, Choi K, Emond J, Vanucci L, Hierro J, Brown S, Broelsch C, Ratain MJ. Quantitation of mitoxantrone in liver tissue following intraperitoneal and intravenous administration in pigs. Clin Res 35, 865A (1987).

  38. Ratain MJ, Golomb HM. Hairy cell leukemia (Letter). N Engl J Med 317, 902 (1987).

  39. Ratain MJ, Golomb HM, Vardiman JW, Westbrook C, Barker C, Hooberman A, Daly K. Prognostic variables for duration of response of interferon alfa-2b in hairy cell leukemia. Blood 70 (Suppl 1), 236a (1987).

  40. Kaminer LS, Stock W, Wu SH, Barker C, Swartz C, Ratain MJ, Golomb HM. Infectious complications in 286 patients with hairy cell leukemia. Blood 70 (Suppl 1), 202a (1987).

  41. Choi K, Ratain MJ, Williams S, Golick J, Bitran J. Intrapatient and interpatient variability in pharmacokinetics of high-dose oral melphalan. Clin Pharmacol Ther 43, 193 (1988).

  42. Ratain MJ, Schilsky R, Wojack B, Simon T, Vogelzang N, Senejkian E, Guarnieri C, Grimmer D. Phase I and in vitro studies of hydroxyurea and etoposide. Clin Pharmacol Ther 43, 125 (1988).

  43. Ratain MJ, Schilsky RL, Choi KE, Guarnieri C, Grimmer D, Vogelzang NJ, Senekjian E, Liebner MA. Adaptive control of etoposide dosing. Proc Am Soc Clin Oncol 7, 69 (1988).

  44. Ratain MJ, Staubus AE, Schilsky RL, Malspeis L. Limited sampling models for amonafide pharmacokinetics. Proc Am Assoc Cancer Res 29, 193 (1988).

  45. Moormeier J, Ratain MJ, Westbrook C, Vardiman J, Daly K, Golomb HM. Low dose interferon in the treatment of hairy cell leukemia. Proc Am Assoc Cancer Res 29, 215 (1988).

  46. Ratain MJ, Golomb H, Vardiman J, Westbrook C, Hooberman A, Bitter M, Daly K. Relapse after interferon alfa-2b therapy for hairy cell leukemia. XXII Congress of the International Society of Hematology (1988).

  47. Ratain MJ, Larson RA, Hooberman A, Pape L, Wallenberg J, Marcus S. Phase II study of recombinant beta interferon in chronic myelogenous leukemia. Blood 72 (Suppl 1), 222a (1988).

  48. Moormeier J, LeBeau M, Hooberman A, Ratain MJ, Golomb HM. A familial lymphoproliferative disorder with fragile site analysis. Blood 72 (Suppl 1), 217a (1988).

  49. Golomb HM, Ratain MJ, Fefer A, Thompson J. Portlock CS, Ozer H, Chiavello J, Israel RJ. Low dose alfa-2b-interferon (0.2 MU/m2 thrice weekly) for the induction of remission of hairy cell leukemia. Blood 72 (Suppl 1), 201a (1988).

  50. Ratain MJ, Choi KE, Liebner MA, Grayhack J, Foody N, Schilsky RL. Phase II and pharmacodynamic study of amonafide in advanced pancreatic cancer. Sixth NCI EORTC Symposium on New Drugs in Cancer Therapy (1989).

  51. Schilsky RL, Ratain MJ, Grayhack J, Breedlove K, Lucas S, Tuttle R. Phase I clinical trial of BW A502U HCL administered by 24 hour continuous intravenous infusion. Sixth NCI EORTC Symposium on New Drugs in Cancer Therapy (1989).

  52. Ratain MJ, Robert J, van der Vijgh WJF. Limited sampling models for doxorubicin pharmacokinetics. Proc Am Soc Clin Oncol 8, 75 (1989).

  53. Schilsky RL, Ratain MJ, Grayhack J, Vogelzang N, Breedlove K, Lucas S, Tuttle R. Phase I clinical and pharmacologic study of BW A502U HCL administered by 24 hour continuous intravenous infusion. Proc Am Soc Clin Oncol 8, 75 (1989).

  54. Egorin MJ, Forrest A, Belani CP, Ratain MJ, Abrams JS, Van Echo DA. A limited sampling strategy for cyclophosphamide pharmacokinetics. Proc Am Soc Clin Oncol 8, 63 (1989).

  55. Ratain MJ, Wojack BR, Safa AR. Modulation of vinblastine effects in sensitive CEM cells. Proc Am Assoc Cancer Res 30, 567 (1989).

  56. Ratain MJ. Individualizing the dosing of cancer chemotherapy using continuous infusion and limited sampling strategies. Proc Am Assoc Cancer Res 30, 666 (1989).

  57. Ratain MJ, Schilsky RL, Staubus AE, Malspeis L. Reply (Letter). Cancer Res 49, 3139-3140 (1989).

  58. Ratain MJ, Schilsky RL, Vogelzang NJ, Grayhack JA, Watson S, Berezin FS, Liebner MA. Individualized dosing of etoposide: A possible means of increasing dose-intensity. Clin Res 37, 946A (1989).

  59. Ratain MJ, Golomb HM, Vardiman JW, Westbrook CA, Moormeier J, Hooberman A, Daly K. Interferon alfa-2b therapy for hairy cell leukemia in 69 patients: A 6-year update. Blood 74 (Suppl 1), 76a (1989).

  60. Lichtman S, Ratain MJ, Budman DR, Norton L, Egorin M, Propert K, Modeas C, Paterson D, Van Echo DA. Phase I trial of recombinant granulocyte-macrophage colony stimulating factor plus cyclophosphamide in solid tumors. Blood 74 (Suppl 1), 328a (1989).

  61. Ratain MJ, Schilsky RL. Response (Letter). J Natl Cancer Inst 81, 1510 (1989).

  62. Ratain MJ, Schilsky RL, Vogelzang NJ, Berezin FS, Mick R. Adaptive control dosing of etoposide: A means of safely increasing dose-intensity. Clin Pharmacol Ther 47, 206 (1990).

  63. Ratain MJ, Vogelzang NJ, Janisch L, Schilsky RL, Stock W, Gressler V, Levitt D. Phase I study of subcutaneous interleukin-2 and interferon alfa-2a. Proc Am Soc Clin Oncol 9, 200 (1990).

  64. Schilsky RL, Ratain MJ, Liebner MA, Choi KE, Berezin F, Guaspari A. Comparative clinical pharmacokinetics of high dose oral and intravenous leucovorin. Proc Am Soc Clin Oncol 9, 65 (1990).

  65. Lichtman S, Ratain M, Budman DR, Norton L, Egorin M, Zuhowski E, O'Brien S, Propert K, Modeas C, Van Echo DA. Phase I trial of recombinant granulocyte-macrophage colony stimulating factor plus high dose cyclophosphamide in solid tumors. Proc Am Soc Clin Oncol 9, 66 (1990).

  66. Samuels B, Ratain M, Safa A, Harrison H, Warfield E, Vogelzang N, Schilsky O'Brien S, Watson S, Mick R, Richards J. Phase I trial of vinblastine with continuous infusion cyclosporine A as a modulator of multidrug resistance. Proc Am Soc Clin Oncol 9, 74 (1990).

  67. Miller CB, Platanias LC, Ratain MJ, Hart RD, Ettinger DS, Mills SR, Jones RJ. A phase I/II trial of erythropoietin in the treatment of chemotherapy-induced anemia in patients with cancer. Proc Am Soc Clin Oncol 9, 194 (1990).

  68. Golomb H, Fefer A, Golde D, Ozer H, Portlock C, Silber R, Rappeport J, Ratain M, Thompson J, Bonnem E, Spiegel R, Tensen L, Burke J, Vardiman J. Update of a multi-institutional study of 195 patients with hairy cell leukemia treated with interferon alfa-2b. Proc Am Soc Clin Oncol 9, 215 (1990).

  69. Schilsky RL, Ratain M, Grayhack J, Janisch L, Breedlove K, Vogelzang N, Lucas S, Tuttle R. Phase I clinical and pharmacologic study of BW A502U HCL administered by 24 hour continuous intravenous infusion. Proc Am Assoc Cancer Res 31, 179 (1990).

  70. Ratain MJ, Propert K, Costanza M, Allen S, Berezin F, Schilsky RL, Van Echo DA. Population pharmacodynamic study of amonafide: CALGB 8862. Proc Am Assoc Cancer Res 31, 181 (1990).

  71. Vokes EE, Raschko J, Vogelzang NJ, Warfield EE, Flanagan B, Ratain MJ, Doroshow JH, Schilsky RL. Five day infusion fluorodeoxyuridine with oral leucovorin: a phase I study. Proc Am Assoc Cancer Res 31, 179 (1990).

  72. Riggs CE, Davis RT, Ratain MJ, Schilsky R, Vogelzang NJ, Geick J, Jarnow L, O'Brien S, Denger P. Pharmacokinetics of Adriamycin in combination with human tumor necrosis factor: results from a phase I trial. Proc Am Assoc Cancer Res 31, 179 (1990).

  73. Mick R, Ratain MJ, Golomb HM. Duration of response after interferon treatment of hairy cell leukemia (Letter). Blood 75, 2465-2466 (1990).

  74. Platanias LC, Miller CB, Jones RJ, Hart RD, Ozer H, Ratain MJ. Treatment of chemotherapy induced anemia in cancer patients with recombinant human erythropoietin. Clin Res 38, 844A (1990).

  75. Ellis ED, Williams SF, Moormeier JA, Bitran JD, Ratain MJ. Phase I study of high dose amonafide with autologous bone marrow rescue. Clin Res 38, 843A (1990).

  76. Miller CB, Platanias LC, Ratain MJ, Hart RD, Ozer H, Ettinger DS, Mills SR, Jones RJ. A phase I/II trial of erythropoietin in the treatment of chemotherapy-induced anemia. Blood 76 (Suppl 1), 156b (1990).

  77. Ratain MJ. Book review: Cancer Chemotherapy: Principles and Practice. J Natl Cancer Inst 82, 1644-1645 (1990).

  78. Ratain MJ. Dose reduction of etoposide in jaundiced patients (Letter). J Clin Oncol 8, 2088 (1990).

  79. Ratain MJ. The future of pharmacodynamic models in the design of clinical trials of chemotherapy. Third International Congress on Neo-Adjuvant Chemotherapy (1991).

  80. Ratain MJ, Berezin F, Allen SL, Costanza M, Propert K, Van Echo DA, Schilsky RL. Rapid acetylators of amonafide have enhanced myelosuppression. Clin Pharmacol Ther 49, 196 (1991).

  81. Mick R, Ratain MJ. Quantitative assessment of accumulating data in phase I cancer clinical trials. Clin Pharmacol Ther 49, 155 (1991).

  82. Allen SL, Ratain M, Korzun AH, Duggan D, Nowak B, Norton L, Henderson IC. Phase II study of amonafide in previously treated metastatic breast cancer (CALGB 8841). Proc Am Assoc Cancer Res 32, 183 (1991).

  83. Vokes EE, Weichselbaum RR, Ratain MJ, McEvilly J-M, Ervin TJ, Wenig B, Berezin F, Haraf D, Schilsky RL, Kozloff MF, Panje WR. PFL with escalating doses of interferon-alpha-2b as neoadjuvant chemotherapy for stage IV head and neck cancer: A clinical and pharmacokinetic analysis. Proc Am Soc Clin Oncol 10, 693 (1991).

  84. Ratain MJ, Mick R, Berezin F, Janisch L, Schilsky RL, Williams SF, Smiddy J. Prospective correlation of acetylator phenotype with amonafide toxicity. Proc Am Soc Clin Oncol 10, 101 (1991).

  85. Mick R, Ratain MJ. Modeling interpatient pharmacodynamic variability of etoposide. Proc Am Soc Clin Oncol 10, 101 (1991).

  86. Vokes EE, Ratain MJ, O'Brien S, Berezin F, Schilsky RL, Vogelzang NJ. Five day infusional fluorodeoxyuridine with oral leucovorin and escalating doses of interferon-alpha-2B: A clinical and pharmacokinetic study. Proc Am Assoc Cancer Res 32, 177 (1991).

  87. Priest ER, Ratain MJ, Janisch L, Vogelzang NJ. Outpatient subcutaneous Interleukin-2 and Interferon alfa-2A: A phase I study. Proc Am Assoc Cancer Res 32, 191 (1991).

  88. Samuels B, Ratain M, Mick R, Vogelzang NJ, Schilsky R, O'Brien S, Harrison H. Phase I trial of multidrug resistance modulation with cyclosporine A. Proc Am Assoc Cancer Res 32, 195 (1991).

  89. O'Brien SM, Ratain MJ, Mick R, Schilsky RL, Vogelzang NJ. Prognostic factors for rigors in patients receiving tumor necrosis factor. Proc Am Soc Clin Oncol 10, 1221 (1991).

  90. Lichtman S, Ratain M, Van Echo D, Budman DR, Norton L, Egorin M, Vogelzang N, Williams S, Modeas C, O'Brien S, Yerys C, Whitacre M, Schilsky R. Phase I trial of recombinant granulocyte-macrophage colony stimulating factor plus high dose biweekly cyclophosphamide in solid tumors. Proc Am Assoc Cancer Res 32, 192 (1991).

  91. Samuels BL, Ratain MJ. Correspondence re: Xiu F. Hu et al. Combined use of Cyclosporin A and verapamil in modulating multidrug resistance in human leukemia cell lines (Letter). Cancer Res 51, 1749 (1991).

  92. Golomb HM, Ratain M, Mick R, Daly K. Interferon treatment of hairy cell leukemia; an update of the University of Chicago experience. Fifth International Symposium on Therapy of Acute Leukemias (1991).

  93. Richards JM, Mick R, Latta JM, Daly K, Ratain MJ, Vardiman JW, Golomb HM. Response (letter). Blood 77, 2541-2542 (1991).

  94. Platanias LC, Ratain MJ, O'Brien S, Larson RA, Vardiman JW, Wiliams SF, Baron JM, Parker K, Woodworth TG. Phase I study of genetically engineered DAB486IL-2 in patients with hematologic malignancies. Blood 78 (Suppl 1), 439a (1991).

  95. Geller RB, Janisch L, Larson RA, Vardiman J, Ratain MJ. Phase I trial of hepsulfam in patients with refractory leukemias. Blood 78 (Suppl 1), 53a (1991).

  96. Vokes EE, Wenig B, Haraf DJ, McEvilly JM, Ervin TJ, Ratain MJ, Barton K, Kozloff M, Kies M, Panje WR, Weichselbaum RR. Interferon-alfa-2b as modulator of PFL induction chemotherapy for stage IV head and neck cancer. Eur J Cancer Suppl 2, S199 (1991).

  97. Stock W, Lichtman S, Ratain MJ, O'Brien S, Vogelzang NJ, Van Echo DA. Response to high dose cyclophosphamide with GM-CSF in Merkel cell tumor (Letter). Ann Oncol 2, 522-523 (1991).

  98. Ratain MJ, Mick R, Berezin F, Janisch L, Schilsky RL, Vogelzang NJ. Phase I study of amonafide dosing based on acetylator phenotype. Ann Oncol 3(Suppl 1), 148 (1992).

  99. Schilsky RL, Janisch L, Berezin F, Walter P, Vogelzang NJ, Ratain MJ. Phase I clinical and pharmacologic study of iododeoxyuridine and bleomycin in patients with advanced cancer. Ann Oncol 3(Suppl 1), 150 (1992).

  100. O'Brien SM, Mick R, Schilsky RL, Vogelzang NJ, Holmes P, Ratain MJ. Prognostic factors for rigors in patients receiving tumor necrosis factor. Ann Oncol 3(Suppl 1), 173 (1992).

  101. Berezin F, Schilsky RL, Ratain MJ. Analysis of fostriecin from plasma using solid phase extraction and HPLC. Ann Oncol 3(Suppl 1), 190 (1992).

  102. Vogelzang NJ, Janisch L, Berezin F, Mick R, Schilsky R, Walter P, Ratain MJ. Pyrazine diazohydroxide: a phase I trial using a 5 day schedule. Ann Oncol 3(Suppl 1), 147 (1992).

  103. Janisch L, Mick R, Kut M, O'Brien S, Vogelzang NJ, Schilsky RL, Ratain MJ. Prognostic factors for survival of patients entered on phase I cancer trials. Ann Oncol 3(Suppl 1), 151 (1992).

  104. Ratain MJ, Von Hoff DD, Alberts DS, Foster BJ, Earhart RH. Phase I trial program for adozelesin (U-73,975). Ann Oncol 3(Suppl 1), 160 (1992).

  105. Woodworth T, LeMaistre CF, McCaffrey R, Schnipper L, Rosen S, Ratain M, Phase I/II clinical studies of DAB486IL-2 fusion toxin in patients with refractory IL-2 receptor expressing hematopoietic malignancies. Ann Oncol 3(Suppl 1), 168 (1992).

  106. Benson AB, Mobarhan S, Ratain M, Sheehan T, Berezin F, Giovanazzi-Bannon S, Ford C, Rademaker A. Phase I study of 4-methyl-5-(2-pyrazinyl)-1,2-dithione-3-thiol (oltipraz: RP,35972) in male patients with previously resected colon polyps and first degree relatives of breast cancer patients. Proc Am Soc Clin Oncol 11, 145 (1992).

  107. Geller RB, Janisch L, Kampmeier P, Ratain MJ. Phase I trial of hepsulfam in patients with refractory leukemias. Proc Am Soc Clin Oncol 11, 264 (1992).

  108. Janisch L, Mick R, Kut M, O'Brien S, Vogelzang NJ, Schilsky RL, Ratain MJ. Prognostic factors for survival in patients entered on

  109. phase I cancer trials. Proc Am Soc Clin Oncol 11, 409 (1992).

  110. Platanias LC, Ratain MJ, O'Brien S, Larson RA, Vardiman JW, Williams SF, Baron JM, Parker K, Woodworth TG. Phase I study of DAB486IL-2 in patients with hematologic malignancies. Proc Am Soc Clin Oncol 11, 258 (1992).

  111. Ratain MJ, Berezin F, Allen SL, Costanza ME, Rosner G, Van Echo DA, Schilsky RL. Population pharmacodynamic study of amonafide: CALGB 8862. Proc Am Soc Clin Oncol 11, 117 (1992).

  112. Vokes EE, Ratain MJ, Mick R, Wenig B, Weichselbaum RR, Berezin F, Kozloff M, Haraf DJ, Walter P, Ervin TJ, Hamasaki V, Panje WR, McEvilly J. A clinical and pharmacologic phase I-II study of PFL with interferon alfa-2b for head and neck cancer. Proc Am Soc Clin Oncol 11, 243 (1992).

  113. Kodish ED, Stocking CB, Ratain MJ, Kohrman AF, Siegler M. Ethical issues in phase I oncology research: a study of investigators and institutional review board chairs. Proc Am Soc Clin Oncol 11, 377 (1992).

  114. Berezin F, Ratain MJ, Benson AB. Pharmacokinetic study of 4-methyl-5(2-pyrazinyl)-1,2-dithiole-3-thione (oltipraz) in normal volunteers. Proc Am Assoc Cancer Res 33, 208 (1992).

  115. Fleming GF, Ratain MJ, O'Brien SM, Vogelzang NJ, Earhart RH. Phase I study of adozelesin by 24 hour infusion. Proc Am Assoc Cancer Res 33, 265 (1992).

  116. Mitchell RB, Dolan ME, Janisch L, Ratain MJ, Schilsky RL. A phase I study of a unique schedule of dacarbazine and carmustine. Proc Am Assoc Cancer Res, 33, 236 (1992).

  117. Vogelzang NJ, Janisch L, Berezin F, Mick R, Schilsky R, Walter P, Ratain MJ. Pyrazine diazohydroxide: A phase I trial. Proc Am Assoc Cancer Res 33, 532 (1992).

  118. Vokes E, Krishnasamy S, Dolan E, Ratain M, Dohrmann G, Hekmatpanah J, Kolker J, Weichselbaum R, Schilsky R, Berezin F, Walter P. 5-Fluorouracil, Hydroxyurea with escalating doses of Iododeoxyuridine and concomitant radiotherapy for malignant gliomas: A clinical and pharmacologic analysis. Proc Am Assoc Cancer Res 33, 212 (1992).

  119. Larson RA, Le Beau MM, Ratain MJ, Rowley JD. Balanced translocations involving chromosome bands 11q23 and 21q22 in therapy-related leukemia (Letter). Blood 79, 1892-1893 (1992).

  120. Spielberger RT, O'Brien S, Ratain MJ, Larson RA. Phase I study of 2-chlorodeoxyadenosine in hematologic malignancies. Clin Res 40, 738A (1992).

  121. Lestingi TM, Vogelzang NJ, Richards JM, Janisch L, Ratain MJ. Phase I trial of interleukin-1a and recombinant interleukin-2. Clin Res 40, 691A (1992).

  122. Kobayashi K, Vokes EE, Janisch L, Berezin F, Vogelzang NJ, Ratain MJ. A phase I cohort study of suramin in patients with advanced cancer. Clin Res 40, 738A (1992).

  123. Ratain MJ. Systemic therapy of hairy cell leukemia. Cancer Invest 11(Suppl 1), 28-29 (1992).

  124. Spielberger RT, O'Brien S, Ratain MJ, Williams SF, Larson RA. Phase I study of 2-chlorodeoxyadenosine in hematologic malignancies. Blood 80 (Suppl 1), 460a (1992).

  125. Woodworth TG, LeMaistre CF, McCaffrey R, Schipper L, Rosen S, Ratain M. Phase I/II clinical studies of DAB486IL-2 fusion toxin in patients with refractory IL-2 receptor expressing malignancies. Blood 80 (Suppl 1), 158a (1992).

  126. Barton K, Larson RA, O'Brien S, Ratain MJ. Rapid response of B-cell prolymphocytic leukemia to 2-chlorodeoxyadenosine (Letter). J Clin Oncol 10, 1821 (1992).

  127. Kobayashi K, Vokes EE, Stefansson K, Janisch L, Vogelzang NJ, Berezin F, Ratain MJ. Suramin: Is adaptive control necessary? (Letter). J Clin Oncol 110, 1984-1985 (1992).

  128. Mick R, Ratain MJ, Berezin F, Janisch L, Schilsky RL, Vogelzang NJ, Willliams S, Lane LB, Kut M. Individualized dosing of amonafide. Clin Pharmacol Ther 53, 232 (1993).

  129. Kobayashi K, Vogelzang NJ, O'Brien S, Schilsky RL, Ratain MJ. A phase I study of 2-chlorodeoxyadenosine in solid tumors. Clin Pharmacol Ther 53, 232 (1993).

  130. Schilsky RL, Gale D, Berezin F, Ramirez J, Vokes E, Ratain MJ. Phase I clinical and pharmacokinetic study of fostriecin administered daily for 5 consecutive days. Fourth International Congress on Anti-Cancer Chemotherapy (1993).

  131. Berezin F, Ramirez J, Schilsky RL, Ratain MJ. High performance liquid chromatography assay for fostriecin in biological fluids. Proc Am Assoc Cancer Res 34, 379 (1993).

  132. Vokes EE, Dolan ME, Ratain MJ, Ramirez J, McEvilly JM, Luckett P, Haraf DJ, Weichselbaum RR, Kies M, Kozloff M. Cisplatin, fluorouracil, l-leucovorin and interferon alfa-2b for advanced head and neck cancer: A pharmacologic analysis. Proc Am Assoc Cancer Res 34, 205 (1993).

  133. Fleming GF, Schilsky RL, O'Brien SM, Berezin FK, Mick R, Vogelzang NJ, Ramirez J, Ratain MJ. Phase I and pharmacologic study of 5-fluorouracil in patients with hepatic or renal dysfunction. Proc Am Assoc Cancer Res 34, 396 (1993).

  134. Lestingi TM, Ratain MJ, Mick R, Gale D, Kut M, Levitt D. A pharmacodynamic study of recombinant human interleukin-6 and carboplatin: A novel study design to investigate a new hematopoietic growth factor. Proc Am Assoc Cancer Res 34, 216 (1993).

  135. Ratain MJ, Rosner G, Duggan D, Cobau C, Berezin F, Henderson IC, Schilsky RL. Population pharmacodynamic study of single-agent doxorubicin in women with stage III breast cancer: CALGB 8968. Proc Am Soc Clin Oncol 12, 140 (1993)

  136. Spielberger RT, Larson RA, O'Brien SM, Williams SF, Ratain MJ. Phase I study of 2-chlorodeoxyadenosine by 1 hour bolus infusion in hematologic malignancies. Proc Am Soc Clin Oncol 12, 141 (1993).

  137. Samuels B, O'Brien S, Vogelzang N, Williams S, Schilsky R, Bitran J, Stone L, Ratain M. Phase I trial of double modulation of multidrug resistance with cyclosporine A and tamoxifen. Proc Am Soc Clin Oncol 12, 161 (1993).

  138. Stadler WM, Vogelzang NJ, Ratain MJ, Mick R, Richards JM. Physician bias in the entry of patients with metastatic renal cell cancer in phase I trials. Proc Am Soc Clin Oncol 12, 249 (1993).

  139. O'Brien SM, Ratain MJ, Mick R, Schilsky RL, Vogelzang NJ, Holmes P. Phase I study of mitomycin-C and tumor necrosis factor. Proc Am Soc Clin Oncol 12, 299 (1993).

  140. Lestingi TM, Vogelzang NJ, Richards JM, Janisch L, Platanias LC, Mick R, Ratain MJ. Phase I trial of recombinant interleukin-1a and recombinant interleukin-2. Proc Am Soc Clin Oncol 12, 298 (1993).

  141. Kobayashi K, Vokes EE, Janisch L, Berezin F, Lane LB, Vogelzang NJ, Ratain MJ. A phase I cohort study of suramin in patients with advanced cancer. Proc Am Soc Clin Oncol 12, 161 (1993)

  142. Daugherty C, Ratain M, Mick R, Siegler M. A proposal for a new phase I clinical trial design: patient choice dose cohort. Clin Res, 41, 662A (1993).

  143. Stupp R, Stocking C, Ratain M, Richardson J, List M, Siegler M. The value of supportive care and prevention of side effects to the patient. Clin Res 41, 645A (1993).

  144. Daugherty C, Ratain M, Mick R, Siegler M. A proposal for a new phase I clinical trial design: patient choice dose cohort. Clinical Trials in Oncology: Improving their Design and Analysis (1993).

  145. Ratain MJ. Pharmacogenetics of amonafide: an active drug in breast cancer? Cancer Invest 12 (Suppl 1), 38 (1993).

  146. Kobayashi K, Vokes EE, Janisch L, Parks C, Vogelzang NJ, Ratain MJ. A phase I study of suramin in patients with advanced cancer. Clin Pharmacol Ther 55, 190 (1994).

  147. Karlsson MO, Port RE, Ratain MJ, Sheiner LB. A population model for the leukopenic effect of etoposide. Clin Pharmacol Ther 55, 152 (1994).

  148. Lilenbaum RC, Green MR, Hargis JB, Ratain MJ, Miller AA, Rosner GL, Schilsky RL. Phase I study of taxol and topotecan in patients with advanced solid tumors. Ann Oncol 5 (Suppl 5), 192 (1994).

  149. Fleming GF, Schilsky RL, Mick R, O'Brien SM, Vogelzang NJ, Ratain MJ. Circadian variation of 5-fluorouracil plasma levels during continuous-infusion 5-FU and leucovorin in patients with hepatic or renal dysfunction. Ann Oncol 5 (Suppl 5), 131 (1994)

  150. Kobayashi K, Vokes EE, Janisch L, Weiss R, Vogelzang NJ, Ratain MJ. A phase I study of suramin in patients with advanced cancer. Ann Oncol 5 (Suppl 5), (1994).

  151. Schilsky RL, Ramirez J, Wilson K, Vokes E, Kobayashi K, Berezin F, Wulff W, Ratain MJ. Phase I clinical and pharmacokinetic study of fostriecin in patients with advanced cancer. Ann Oncol 5 (Suppl 5), 188 (1994).

  152. Ratain MJ, Strocchi E, Leyland-Jones B, Camaggi CM. Limited sampling models to simultaneously estimate idarubicin and its active metabolite idarubicinol. Ann Oncol 5 (Suppl 5), 174 (1994).

  153. Mick R, Lane N, Daugherty C, Ratain MJ. Physician attitudes on toxicity risk assessment and decision-making in phase I trials. Ann Oncol 5 (Suppl 5), 134 (1994).

  154. Mick R, Ratain MJ. Bootstrap validation of pharmacodynamic models defined via stepwise linear regression. Ann Oncol (Suppl 5), 169 (1994)

  155. Lestingi TM, Ratain MJ, Mick R, Janisch L, Schilsky RL, Vogelzang NJ, Isaacs R, Levitt D. A pharmacodynamic study of recombinant human interleukin-6 and carboplatin. Ann Oncol 5 (Suppl 5), 108 (1994)

  156. Ratain MJ. Polymorphic metabolism and pharmacodynamics of amonafide. Proc Am Assoc Cancer Res 35, 686-687 (1994).

  157. Schilsky RL, Ramirez J, Wilson K, Vokes E, Kobayashi K, Berezin F, Wulff W, Ratain MJ. Phase I clinical and pharmacologic study of fostriecin in patients with advanced cancer. Proc Am Soc Clin Oncol 13, 132 (1994).

  158. Fleming GF, Schilsky RL, Mick R, O'Brien SM, Vogelzang NJ, Ratain MJ. Circadian variation of 5-fluorouracil and cortisol plasma levels during continuous-infusion 5-FU and leucovorin in patients with hepatic or renal dysfunction. Proc Am Soc Clin Oncology 13, 139 (1994).

  159. Mick R, Lane N, Daugherty C, Ratain MJ. Physician opinion on toxicity risk assessment and decision-making in phase I trials. Proc Am Soc Clin Oncol 13, 157 (1994)

  160. Daugherty C, Ratain MJ, Kodish E, Mick R, Grochowski E, Stocking C, Siegler M. Patients participating in phase I trials in oncology: influences, motivations, and comprehension. Proc Am Soc Clin Oncol 13, 441 (1994).

  161. Lilenbaum RC, Rosner GL, Ratain MJ, Hargis JB, Miller AA, Green MR, Schilsky RL. Phase I study of Taxol and topotecan in patients with advanced solid tumors. Proc Am Soc Clin Oncol 13, 131 (1994).

  162. Kobayashi K, Vokes EE, Janisch L, Vogelzang NJ, Ratain MJ. Suramin (SUR) is safe and active in prostate cancer without adaptive control: evidence for dose-response. Proc Am Soc Clin Oncol 13, 140 (1994).

  163. Samuels BL, O'Brien SM, Vogelzang NJ, Bitran JD, Schilsky RL, Williams SF, Ratain MJ. Phase I trial of double modulation of multi-drug resistance with cyclosporine A and tamoxifen. Proc Am Soc Clin Oncol 13, 164 (1994).

  164. Lestingi TM, Vokes EE, Mick R, Fleming GF, Schilsky RL, Shah A, Harder S, Gray W, Ratain MJ. A pharmacokinetic and pharmacodynamic study of etoposide combined with recombinant human interferon alfa-2b. Proc Am Soc Clin Oncol 13, 139 (1994).

  165. Lestingi TM, Ratain MJ, Mick R, Schilsky RL, Vogelzang NJ, Janisch L, Isaacs R, Levitt D. A pharmacodynamic study of recombinant human interleukin-6 and carboplatin. Proc Am Soc Clin Oncol 13, 141 (1994).

  166. Arora R, Dhand UK, Kobayashi K, Vokes EE, Martin B, Janisch L, Ratain MJ, Soliven B. Evaluation of neuropathy in patients on suramin treatment. Neurology 44 (Suppl 2), A306 (1994).

  167. Grochowski E, Daugherty C, Siegler M, Kodish E, Ratain MJ. Expectations of oncologists in phase I cancer trials. Society of General Internal Medicine (1994).

  168. Weiss RE, Kobayashi K, Ratain MJ, Vokes E, Vogelzang NJ. The chronic effect of suramin on adrenal function: impaired glucocorticoid and mineralcorticoid reserve. Proc Endo Soc 76, 289 (1994).

  169. Gupta E, Ramirez J, Ratain MJ. Role of carboxylesterase in the metabolism of CPT-11, a camptothecin analog, in humans. Pharmaceut Res 11, S-450 (1994).

  170. Mick R, Ratain MJ. Phase I study of escalating doses of carboplatin (Letter). Cancer Chemother Pharmacol 34, 535-536 (1994).

  171. Daugherty CK, Ratain MJ, Grochowski E, Kodish E, Mick R, Stocking C, Siegler M. Phase I trials: expectations of cancer patients and their oncologists. Clin Res 42, 370A (1994).

  172. Gupta E, Lestingi TM, Mick R, Ramirez J, Vokes EE, Ratain MJ. Relationship of CPT-11 induced diarrhea to glucuronidation of its metabolite SN-38. Clin Res 42, 394A (1994).

  173. Gupta E, Dolan ME, Mick R, Wang X, De Leon M, Baker T, Benson AB, Ratain MJ, Olopade OI. Phase I clinical evaluation of oltipraz as a chemopreventive agent. Clin Pharmacol Ther 57, 176 (1995)

  174. Kobayashi K, Vokes EE, Ratain MJ. A population pharmacokinetic study of suramin by intermittent infusion in patients with advanced cancer. Clin Pharmacol Ther 57, 181 (1995).

  175. Skoog LA, Ratain MJ, O'Brien SM, Schilsky RL, Vogelzang NJ, Gerber M, Narang PK, Nicol SJ. Phase I trial of methoxymorpholinodoxorubicin (FCE23762) on a daily x3 schedule. Proc Am Soc Clin Oncol 14, 485 (1995).

  176. Kobayashi K, Vokes EE, Ratain MJ. A NONMEM population pharmacokinetic model for suramin: effect of weight and albumin. Proc Am Soc Clin Oncol 14, 462 (1995).

  177. Vokes EE, O'Brien SM, Schilsky RL, Vogelzang NJ, Joshi A, Winslow DL, Ratain MJ. A phase I study of high-dose DuP941 (losoxantrone) in combination with cyclophosphamide. Proc Am Soc Clin Oncol 14, 478 (1995).

  178. Mick R, Larson RA, O'Brien S, Ratain MJ. Pharmacodynamic evaluation of a phase I trial of cladribine in advanced hematologic malignancies. Proc Am Soc Clin Oncol 14, 477 (1995)

  179. Gupta E, Safa AR, Ratain MJ. P-glycoprotein mediated excretion of CPT-11 and SN-38: effect of cyclosporine A. Proc Am Soc Clin Oncol 14, 490 (1995).

  180. Vokes EE, Mick R, Kies M, Malone D, Dolan M, Athanasiadis I, Haraf DJ, Mittal B, Kozloff M, Weichselbaum RR, Ratain MJ. Fluorouracil pharmacodynamics of induction chemotherapy in advanced head and neck cancer. Proc Am Soc Clin Oncol 14, 297 (1995)

  181. Fleming GF, O'Brien SM, Hoffman PC, Vokes EE, Vogelzang NJ, Schilsky RL, Ratain MJ. Phase I trial of interferon-a2a and 13-cis-retinoic acid combined with cisplatin, 5-fluorouracil and leucovorin in patients with advanced solid tumors. Proc Am Soc Clin Oncol 14, 485 (1995).

  182. Schaaf LJ, Vogelzang NJ, Chambers JH, Janisch L, Earhart RH, Gutnecht GD, Ratain MJ. Effect of food and comparative bioavailability of orally administered bropirimine in solid tumor patients. Proc Am Soc Clin Oncol 14, 462 (1995)

  183. Lestingi TM, Vokes EE, Gray W, Schilsky RL, Vogelzang NJ, Mick R, Gupta E, Ratain MJ. A phase I trial of CPT-11 in solid tumors with G-CSF and antidiarrheal support. Proc Am Soc Clin Oncol 14, 480 (1995).

  184. Benson AB, Olopade OI, Dolan ME, Mobarhan S, Ratain M, Stucky-Marshall L, Gupta E, Harder S, Rademaker A. Phase I studies of single dose (normal volunteers) and daily low dose 4-methyl-5-(2-pyrazinyl)-1,2-dithione-3-thiol [oltipraz; RP, 35972] in patients with resected colon polyps and first degree female relatives of breast cancer patients. Proc Am Soc Clin Oncol 14, 165 (1995).

  185. Gupta E, Wang XL, Ratain MJ. CPT-11-valproic acid pharmacokinetic interaction and effect of biliary excretion in rats. Pharmaceut Res 12, S-329 (1995).

  186. Kuzel T, Foss F, LeMaistre C, Platanias L, Ratain M, Rook A, Saleh M, Schwartz G. Phase I trial of a diphtheria toxin fusion protein (DAB389 IL-2) for the treatment of interleukin-2 receptor expressing hematologic neoplasms. Blood 86 (Suppl 1), 274a (1995).

  187. Gupta E, Mick R, Wang X, Vokes EE, Ratain MJ. Pharmacokinetic-pharmacodynamic analysis of intestinal toxicity associated with irinotecan: validation of biliary index. Clin Pharmacol Ther 59, 197 (1996).

  188. Cantilena LR, Ratain MJ. Fostriecin nephrotoxicity: an in vitro assessment. Clin Pharmacol Ther 59, 161 (1996).

  189. Lilenbaum RC, Miller AA, Batist G, Hollis DR, Rosner GL, Schilsky RL, Ratain MJ. Phase I study of continuous IV infusion topotecan in combination with cisplatin in patients with advanced cancer (CALGB 9462). Ann Oncol 7 (Suppl 1), 132 (1996).

  190. LeMaistre F, Foss F, Kuzel T, Platanias L, Ratain M, Rook A, Saleh M, Schwartz G, Nichols J. DAB389 IL2, a new diphtheria toxin fusion protein displays antitumor activity in interleukin-2 receptor-expressing non-Hodgkin's lymphoma. Ann Oncol 7 (Suppl 1), 54 (1996).

  191. Kobayashi K, Vokes EE, Janisch LJ, Vogelzang NJ, Ratain MJ. A phase I study of suramin given by 2-day intermittent infusion without adaptive control in patients with advanced cancer. Ann Oncol 7 (Suppl 1), 54 (1996).

  192. Vokes EE, Ansari R, Minami H, Masters GA, Hoffman PC, Sciortino D, Kugler JW, Golomb HM, Ratain MJ. A phase II and pharmacological study of 9-aminocamptothecin in advanced non-small cell lung cancer. Ann Oncol 7 (Suppl 1), 130 (1996)

  193. Mick R, Gupta E, Vokes EE, Ratain MJ. Limited sampling model for irinotecan (CPT-11) pharmacokinetics-pharmacodynamics: prediction of biliary index and its resulting intestinal toxicity. Ann Oncol 7 (Suppl 1), 129 (1996).

  194. Brockstein B, Vogelzang N, Schilsky R, Stadler W, Hoehne C, Sciortino D, Gibbons J, Ansari R, Garcia J, Ratain M, Vokes E. Pyrazine diazohydroxide (PZDH): Lack of efficacy in phase II studies of colorectal and renal carcinoma. Ann Oncol 7 (Suppl 1), 137 (1996).

  195. Gupta E, Mick R, Wang X, Vokes EE, Ratain MJ. Pharmacokinetic-pharmacodynamic analysis of intestinal toxicity associated with irinotecan (CPT-11): validation of biliary index. Ann Oncol 7 (Suppl 1), 129 (1996).

  196. Burris H, Von Hoff D, Ratain M, Khor S, Lucas S, Spector T, Smetzer L, Janisch L, Schilsky R. Initial phase I trial of the dihydropyrimidine dehydrogenase inactivator 5-ethynyluracil (776C85) plus 5-fluorouracil. Ann Oncol 7 (Suppl 1), 29 (1996).

  197. Lilenbaum RC, Miller AA, Batist G, Hollis DR, Rosner GL, Schilsky RL, Ratain MJ. Phase I study of continuous iv infusion topotecan in combination with cisplatin in patients with advanced cancer (CALGB 9462). Proc Am Soc Clin Oncol 15, 485 (1996).

  198. Ratain MJ, Mick R, Gupta E, Lestingi TM, Schilsky RL, Vokes EE. Prospective evaluation of the effect of race and gender on irinotecan pharmacokinetics and intestinal toxicity. Proc Am Soc Clin Oncol 15, 472 (1996).

  199. Schilsky RL, Burris H, Ratain M, Von Hoff D, Janisch L, Smetzer L, Lucas VS, Khor SP, Hohneker J. Phase I clinical and pharmacologic study of 776C85 plus 5-fluorouracil in patients with advanced cancer. Proc Am Soc Clin Oncol 15, 485 (1996).

  200. Dolan ME, Ratain MJ, Roy S, Gupta E, Paras P, Harder S, Schilsky RL. Pharmacokinetics and pharmacodynamics of O6-benzylguanine in patients with advanced cancer. Proc Am Soc Clin Oncol 15, 176 (1996)

  201. Sciortino DF, Vogelzang NJ, Mick R, Schilsky RL, Gibbons J, Gabrys GT, Hoehne CW, Ansari RH, Brockstein BE, Stadler WM, Garcia JC, Ratain MJ, Vokes EE. Pyrazine diazohydroxide: a pharmacokinetic and clinical analysis of phase II investigations in metastatic colorectal and renal carcinomas. Proc Am Soc Clin Oncol 15, 183 (1996).

  202. Iyer L, Roy SK, Ratain MJ. In vitro glucuronidation of SN38, the active metabolite of irinotecan (CPT-11) in human liver microsomes. Proc Am Soc Clin Oncol 15, 497 (1996).

  203. Daugherty C, Lyman K, Mick R, Siegler M, Ratain MJ. Differences in perception of goals, expectations and level of informed consent between oncologists and patients involved in phase I clinical trials. Proc Am Soc Clin Oncol 15, 530 (1996).

  204. Daugherty C, Lyman K, Minami H, Cooper N, Mick R, Vogelzang N, Stadler W, Siegler M, Ratain MJ. A feasibility study of informed consent and medical decision-making employing an interactive patient choice design in phase I trials. Proc Am Soc Clin Oncol 15, 175 (1996).

  205. Kobayashi K, Ratain MJ, Fleming GF, Vogelzang NJ, Cooper N, Sun BL. A phase I study of CYP3A4 modulation of oral etoposide with ketoconazole in patients with advanced cancer. Proc Am Soc Clin Oncol 15, 471 (1996)

  206. Mick R, Gupta E, Vokes EE, Ratain MJ. Limited sampling model for irinotecan pharmacokinetics-pharmacodynamics: prediction of biliary index and its resulting intestinal toxicity. Proc Am Soc Clin Oncol 15, 472 (1996).

  207. Kobayashi K, Vokes EE, Ratain MJ, Janisch L, Vogelzang NJ. Survival of prostate cancer patients treated with suramin by intermittent infusion without adaptive control: possible negative impact of prior flutamide therapy on survival. Proc Am Soc Clin Oncol 15, 481 (1996).

  208. Vokes E, Johnston P, Recant W, Mick R, Behan K, Dolan E, Ratain M, Beckmann E, Weichselbaum R, Kozloff M, Allegra C. Thymidylate synthase expression in advanced head and neck cancer. Proc Am Soc Clin Oncol 15, 313 (1996).

  209. Skoog LA, Ratain MJ, O'Brien SM, Cooper N, Schilsky RL, Vogelzang NJ, Gerber M, Narang PK, Nicol SJ. Phase I trial of methoxymorpholinodoxorubicin (FCE 23762): on a daily x3 schedule. Proc Am Soc Clin Oncol 15, 482 (1996).

  210. Minami H, Mick R, Vokes EE, Ratain MJ. Pharmacodynamic models for leukopenia and thrombocytopenia of 9-aminocamptothecin. Proc Am Soc Clin Oncol 15, 179 (1996).

  211. Miller AA, Rosner GL, Ratain MJ, Hollis DR, Green MR, Schilsky RL. Pharmacology of 21-day oral etoposide given in combination with intravenous cisplatin for extensive small-cell lung cancer: a Cancer and Leukemia Group B study (CALGB 9062). Proc Am Soc Clin Oncol 15, 472 (1996).

  212. Ansari RH, Masters GA, Hoffman PC, Hoehne C, Critchlow R, Sciortino D, Kuglar JW, Ratain MJ, Golomb HM, Vokes EE. A phase II trial of 9-aminocamptothecin in advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 15, 408 (1996).

  213. Vogelzang NJ, Kobayashi K, Vokes EE, Janisch L, Ratain MJ. Survival of 86 prostate cancer patients treated with suramin by intermittent infusion without adaptive control: Factors affecting survival. Sixth International Prostate Cancer Update (1996).

  214. Brockstein B, Haraf D, Stenson K, Ratain M, Glisson B, Sulzen L, Lippman S, Klepsch A, Levin J, Weichselbaum R, Vokes E. A phase I study of continuous infusion paclitaxel, fluorouracil, and hydroxyurea with concomitant radiotherapy for poor prognosis head and neck cancer. Fourth International Conference on Head and Neck Cancer (1996).

  215. LeMaistre F, Foss F, Kuzel T, Platanias L, Ratain M, Rook A, Saleh M, Schwartz G, Nichols J. Ligand toxin fusion toxins are a new class of therapies with antitumor activity in non-Hodgkins lymphoma. European Haematology Association (1996).

  216. Foss F, Kuzel T, Saleh M, Le Maistre F, Platanias L, Ratain M, Rook A, Schwartz G, Nichols J. A novel diphtheria toxin fusion protein, DAB389 IL-2, demonstrates anti-tumor activity in cutaneous T-cell lymphoma. Ann Oncol 7 (Suppl 3), 233 (1996).

  217. Fleming GF, Hoffman PC, Kugler JW, Bitran JD, Ansari R, Ratain MJ, Klepsch A, Vokes EE. Phase II trial of paclitaxel and topotecan with granulocyte-colony stimulating factor support in stage IV breast cancer. Breast Cancer Res Treat 41, 236 (1996).

  218. Miller AA, Lilenbaum RC, Lynch TJ, Rosner GL, Ratain MJ, Green MR, Schilsky RL. Treatment-related fatal sepsis from topotecan/cisplatin and topotecan/paclitaxel (Letter). J Clin Oncol 14, 1964-1965 (1996).

  219. Kobayashi K, Vokes EE, Vogelzang NJ, Janisch L, Soliven B, Ratain MJ. Phase I study of suramin administered by intermittent infusion without adaptive control to cancer patients: update of two expanded dose levels near the maximally tolerated dose (Letter). J Clin Oncol 14, 2622-2623 (1996).

  220. Kobayashi K, Vokes EE, Vogelzang NJ, Ratain MJ. Data modifications to phase I study of suramin (Letter). J Clin Oncol 14, 2623-2624 (1996).

  221. LeMaistre F, Foss F, Kuzel T, Platanias L, Ratain M, Rook A, Saleh M, Schwartz G, Nichols J. Phase I trial of DAB389IL2, a fusion protein with antitumor activity in non-hodgkins lymphoma. Submitted to ASBMT/AACR (1996).

  222. Iyer L, Whitington P, Roy SK, Ratain MJ. Genetic basis for the glucuronidation of SN-38: role of UGT*1 isoform. Clin Pharmacol Ther 61, 164 (1997).

  223. Schilsky RL, Dolan ME, Cooper N, Roy S, Vogelzang NJ, Ratain MJ. Phase I clinical trial of O6-benzylguanine plus carmustine in patients with advanced cancer. Submitted to Seventh International Congress on Anti-Cancer Treatment (1997).

  224. Iyer L, King C, Tephly T, Ratain MJ. UGT isoform 1.1 glucuronidates SN-38, the active metabolite of irinotecan. Proc Am Soc Clin Oncol 16, 201a (1997).

  225. Kobayashi K, Vokes EE, Vogelzang NJ, Janisch L, Ratain MJ. Suramin without adaptive control: 3 different intermittent infusion schedules are equally safe. Proc Am Soc Clin Oncol 16, 211a (1997).

  226. Daugherty CK, Kiolbasa TA, Siegler M, Ratain MJ. Informed consent in clinical research: a study of cancer patient understanding of consent forms and alternatives of care in phase I clinical trials. Proc Am Soc Clin Oncol 16, 54a (1997).

  227. Fleming GF, Fasanmade A, Janisch L, Kapadia G, Ratain MJ. Phase I clinical and pharmacokinetic study of rhizoxin administered as a 72-hour continuous infusion. Proc Am Soc Clin Oncol 16, 236a (1997).

  228. Mani S, Iyer L, Janisch L, Wang X, Fleming GF, Schilsky RL, Ratain MJ. Phase I clinical and pharmacokinetic study of oral 9-aminocamptothecin (NSC-603071). Proc Am Soc Clin Oncol 16, 201a (1997).

  229. Ratain MJ, Cooper N, Smith R, Vogelzang NJ, Mani S, Shulman K, Lowe PG, Averbuch SD. Phase I study of ZD9331: a novel thymidylate synthase inhibitor. Proc Am Soc Clin Oncol 16, 208a (1997).

  230. Brockstein B, Vogelzang NJ, Kugler J, Stadler W, Vukov A, Dumas M, Klepsch A, Fasanmade A, Ratain MJ, Vokes E. A phase II study of trimethylcolchicinic acid methyl ether d-tartrate in patients with hormone refractory prostate cancer. Proc Am Soc Clin Oncol 16, 329a (1997).

  231. Sobecks RM, Stadler WM, Daugherty CK, Ratain MJ, Vogelzang NJ. Vinorelbine and paclitaxel in relapsed metastatic bladder carcinoma. Proc Am Soc Clin Oncol 16, 344a (1997).

  232. Fagbemi S, Iyer L, Mani S, Vogelzang NJ, Cohn H, Fasanmade A, Ratain MJ. Phase I and pharmacokinetic study of irinotecan administered with cyclosporine A. Proc Am Soc Clin Oncol 16, 219a (1997).

  233. Miller AA, Lilenbaum RC, Hollis DR, Rosner Gl, Batist G, Bernard S, Egorin MJ, Schilsky RL, Ratain MJ. Pharmacologic study of continuous infusion topotecan and cisplatin in patients with advanced cancer: A Cancer and Leukemia Group B Study (CALGB 9462). Proc Am Soc Clin Oncol 16, 200a (1997).

  234. Sweeney PJ, Mundt AJ, Masters G, Fasanmade A, Dolan ME, Witt M, Macdonald RL, Ratain M, Vokes E. Phase I trial of iododeoxyuridine, 5-FU, hydroxyurea and concomitant RT for malignant gliomas: clinical and pharmacologic analysis. Proc Am Soc Clin Oncol 16, 394a (1997).

  235. DeMario MD, Ratain MJ, Vogelzang NJ, Mani S, Vokes EE, Fleming GF, Melton K, Benner S, Lebwohl D. A phase I study of oral uracil/ftorafur plus leucovorin and oral JM-216 each given over 14 days every 28 days: preliminary results. J Invest Med 45, 346A (1997).

  236. Humerickhouse R, Dolan E, Brockstein B, Haraf D, Stenson K, Sulzen L, Wright P, Ratain M, Vokes E. Phase I study of a novel DPD inhibitor GW776C85 and oral 5FU with radiation therapy in patients with recurrent or advanced head and neck cancer. J Invest Med 45, 347A (1997)

  237. Joshi A, Pieniaszek HJ, Richards LE, Davidson AF, Ratain M, Cooper N, Finizio M, Vokes E. Disposition of losoxantrone after intravenous administration of 14C-losoxantrone to cancer patients. J Clin Pharmacol 37, 868 (1997).

  238. Iyer L, Hall D, Das S, Mortell M, Kim S, Ramirez J, DiRienzo A, Ratain MJ. Correlation of UGT1A1 genotype versus SN-38 and bilirubin glucuronidation in human liver samples. Clin Pharmacol Ther 63, 171 (1998).

  239. Ramirez J, Iyer L, Lush RM, Mortell M, Feuer JA, Figg WD, Sausville EA, Ratain MJ. In vitro glucuronidation of flavopiridol (NSC649890) by human liver microsomes. Clin Pharmacol Ther 63, 149 (1998).

  240. Fagbemi S, Ratain MJ, Iyer L, Mani S, Vogelzang NJ, Wang X. Phase I and pharmacokinetic study of irinotecan administered with cyclosporine A. Clin Pharmacol Ther, 63, 163 (1998).

  241. DiRienzo A, Hall D, Iyer L, Ratain MJ. Two new alleles in the promoter of the bilirubin UDP-glucuronosyl transferase 1 (UGT1A1) gene. Clin Pharmacol Ther 63, 207 (1998).

  242. Long L, Ratain MJ, Schilsky RL, Fasanmade AA, Dolan ME. Metabolism and pharmacokinetic modeling of O6-benzylguanine in humans. Proc Am Assoc Cancer Res 39, 324 (1998).

  243. Ratain MJ, DeMario MD, Vogelzang NJ, Mani S, Vokes EE, Fleming GF, Melton K, Johnson S, Benner S, Lebwohl D. A phase I study of oral uracil/ftorafur (UFT) plus leucovorin and oral JM-216 each given over 14 days every 28 days. Proc Am Soc Clin Oncol 17, 201a (1998).

  244. Daugherty CK, Banik DM, Siegler M, Ratain MJ. Medical decision control and awareness of prognosis among advanced cancer patients in early clinical trials: potential factors influencing informed consent and patient understanding. Proc Am Soc Clin Oncol 17, 56a (1998).

  245. DeMario MD, Vogelzang NJ, Janisch L, Tonda M, Amantea MA, Pendyala L, Ratain MJ. A phase I study of liposome-formulated cisplatin (SPI-77 R) given every 3 weeks in patients with advanced cancer. Proc Am Soc Clin Oncol 17, 230a (1998).

  246. Egorin MJ, Venook AP, Rosner G, Hollis D, Mani S, Hawkins M, Byrd J, Hohl R, Budman D, Poplin E, Meropol N, Ratain MJ. Phase I study of gemcitabine in patients with organ dysfunction: CALGB 9565. Proc Am Soc Clin Oncol 17, 187a (1998).

  247. Gordon GS, Mani S, Vogelzang NJ, Bertucci D, Schilsky RL, Stadler WM, Ratain MJ. A phase I study of weekly gemcitabine and prolonged continuous infusion 5-fluorouracil with activity in renal cell carcinoma. Proc Am Soc Clin Oncol 17, 332a (1998).

  248. Humerickhouse R, Dolan E, Brockstein B, Haraf D, Stenson K, Kies M, Sulzen L, Wright P, House L, Ratain MJ, Vokes EE. Phase I study of a novel DPD inhibitor GW776C85 and oral 5-FU with RT in recurrent or advanced head and neck cancer. Proc Am Soc Clin Oncol 17, 394a (1998).

  249. Iyer L, Mortell MA, Azuma R, Yamamoto Y, Ratain MJ. Glucuronidation of TAS-103: a novel anticancer agent. Proc Am Soc Clin Oncol 17, 187a (1998).

  250. Janisch L, Mani S, Schilsky RL, Schumm P, Gleming G, Khor SP, Ertel P, Ratain MJ. Phase I study to determine the effects of food on the absorption of oral 776C85 plus 5-fluorouracil in patients with advanced cancer. Proc Am Soc Clin Oncol 17, 224a (1998).

  251. Masters GA, Melton K, Brockstein BE, Krauss SA, Ratain MJ. A dose escalation study of docetaxel with G-CSF in patients with advanced solid tumors: a phase I trial. Proc Am Soc Clin Oncol 17, 248a (1998).

  252. OReilly S, Mani S, Ratain MJ, Elza Brown K, Johnson S, Vogelzang NJ, Kennedy MJ, Donehower RC, Rugg T. Schedules of 5FU and the matrix metalloproteinase inhibitor marimastat: a phase I study. Proc Am Soc Clin Oncol 17, 217a (1998).

  253. Schilsky RL, Dolan ME, Vogelzang NJ, Mani S, Bertucci D, Cooper N, Roy S, Ratain MJ. Phase I clinical and pharmacologic study of O6benzylguanine plus carmustine (BCNU) in patients with advanced cancer. Proc Am Soc Clin Oncol 17, 198a (1998).

  254. Shepard DR, Kobayashi K, Wang C, Ratain MJ. Population pharmacokinetic determination of the modulation of oral etoposide (VP-16) elimination by oral ketoconazole. Proc Am Soc Clin Oncol 17, 190a (1998).

  255. Lewis J, Vokes EE, Bertucci D, Vogelzang NJ, Mani S, Ratain MJ. A phase I study of raltitrexed (Tomudex) and paclitaxel. Proc Am Soc Clin Oncol 17, 493a (1998).

  256. Mani S, Gordon G, Vogelzang NJ, Bertucci D, Schilsky RL, Stadler WM, Ratain MJ. A phase I trial of continuous infusion 5-fluorouracil and weekly gemcitabine: Updated results of an active combination for renal cell, hepatocellular and colon carcinoma. Ann Oncol 9(Suppl 2), 165 (1998).

  257. Iyer L, Mortell MA, Azuma R, Yamamoto Y, Ratain MJ. Glucuronidation of TAS-103 by uridine diphosphate glucuronosyltransferase (UGT) isoforms 1a1 and 2: Possible implication of TAS-103 toxicity in Gilberts syndrome. Ann Oncol 9(Suppl 2), 61 (1998).

  258. Ratain MJ, Goh BC, Smith R, Bertucci D, Mani S, Vogelzang NJ, Schilsky RL, Hutchison M, Douglass E. Phase I study of ZD9331 using a 5-day short infusion schedule. Ann Oncol 9(Suppl 2), 161 (1998).

  259. Mauer AM, Vogelzang NJ, Janisch L, Mani S, Samara E, Ratain MJ. Phase I study of CEP-2563 dihydrochloride (CEP-2563), a tyrosine kinase inhibitor, in patients with solid tumors. Ann Oncol 9(Suppl 2), 127 (1998).

  260. Shepard DR, Mani S, Janisch L, Fleming GF, Schilsky RL, Ratain MJ. Population pharmacokinetic determination of the effect of food on the pharmacokinetics of oral 5-fluorouracil and eniluracil (766C85, 776). Ann Oncol 9(Suppl 2), 157 (1998).

  261. Mitchell F, Lynn S, Rees C, Judson I, Calvert AH, Ratain M, Diab S, Rowinsky E, Mayne K, Jackman AL. Plasma 2-deoxyuridine as a surrogate marker of thymidylate synthase (TS), inhibition in patients in phase I clinical trials of the TS inhibitor ZD9331. Ann Oncol 9(Suppl 2), 160 (1998).

  262. Vokes EE, Bertucci D, Vogelzang NJ, Mani S, Lowery C, Ratain MJ. A Phase I study of raltitrexed (Tomudex) and paclitaxel. Ann Oncol 9(Suppl 2), 121 (1998).

  263. Amantea MA, DeMario MD, Schwartz G, Vogelzang NJ, Tonda M, Pendyala L. Ratain MJ. Single and multiple dose pharmacokinetics of SPI-77 (Stealth liposomal cisplatin) given every 3 weeks in patients with advanced cancer. Ann Oncol 9(Suppl 2), 121 (1998).

  264. Ratain MJ. General Overview: What can we learn from the drug development of non-cancer drugs? Ann Oncol 9(Suppl 2), 5 (1998).

  265. Vokes EE, Ansari RH, Masters GA, Hoffman PC, Klepsch A, Ratain MJ, Sciortiro DF, Lad TE, Krauss S, Fishkin PAS, Golomb HM. A Phase II study of 9-aminocamptothecin in advanced non-small cell cancer. Ann Oncol 9(Suppl 2), 66 (1998)

  266. DeMario MD, Vogelzang NJ, Janisch L, Humphriss E, Miani S, Tonda M, Amantea MA, Ratain MJ, Pendyala L. A Phase I study of liposome-formulated cisplatin (SPI-77) given every 3 weeks in patients with advanced cancer. Ann Oncol 9(Suppl 2), 122 (1998).

  267. Vokes EE, Humerickhouse R, Dolan E. Brockstein B, Haraf D, Stenson K, Kils M, Salzen L, House L, Ratain MJ. Phase I study of the dihydropyrimidine dehydrogenase inhibitor eniluracil (GW 776 C85) and oral 5-FU with concomitant radiotherapy for recurrent or advanced head and neck cancer. Ann Oncol 9(Suppl 2), 156 (1998).

  268. DeMario M, Vogelzang N, Janisch L, Tonda M, Amantea M, Ratain M. Clinical experience with liposome-formulated cisplatin. Cancer Invest 17(Suppl 1), 69 (1998).

  269. Daugherty CK, Banik DM, Ratain MJ. The relationship between preferences for medical decision control and the outcome of informed consent among advanced cancer patients receiving experimental therapies. Medical Decision Making 18, 468 (1998).

  270. Iyer L, Bergseth AC, Ybazeta G, Relling MV, Ratain MJ, DiRienzo A. High variability in SN-38 glucuronidation in liver samples from African population as predicted by UGT1A1 genotypes. Clin Pharmacol Ther 65, 197 (1999).

  271. Klein C, Kastrissios H, Gupta E, Ratain MJ. A pharmacokinetic model for irinotecan and its metabolites in cancer patients. Clin Pharmacol Ther 65, 197 (1999).

  272. Schilsky R, Schwartz G, Berghorn E, Bertucci D, Ratain M, Zukiwski A, Hausheer AF. Phase I trial of escalating doses of BNP7787 in patients receiving cisplatin and paclitaxel. Proc Am Soc Clin Oncol 18, 169a (1999).

  273. Akerley W, Herndon J, Egorin MJ, Lyss A, Kindler H, Savarese D, Sherman CA, Rosen MD, Ratain M, Green MR. CALGB 9731: phase II trial of weekly paclitaxel for advanced non-small cell lung cancer. Proc Am Soc Clin Oncol 18, 462a (1999).

  274. Holmland JT, Rudin CM, Mani S, Fleming GF, Stadler W, Kunkel K, Kwoh TJ, Geary R, Dorr A, Ratain MJ. Phase I trial of ISIS 5132/ODN 698A, a 20-mer phosphorothioate antisense oligonucleotide inhibitor of C-raf kinase, administered by a 24-hour weekly intravenous infusion to patients with advanced cancer. Proc Am Soc Clin Oncol 18, 157a (1999).

  275. DeMario MD, Shepard DR, Janisch LA, Fleming GF, Ratain MJ. A phase I trial of carboxyamido-triazole in patients with advanced malignancies. Proc Am Soc Clin Oncol 18, 158a (1999).

  276. Mani S, Shulman K, Kunkel K, Geary R, Holmland JT, Dow A, Rudin CM, Ratain MJ. Phase I trial of protein kinase-C a antisense oligonucleotide (ISIS 3521; ISI 641A) with 5-fluorouracil and leucovorin in patients with advanced cancer. Proc Am Soc Clin Oncol 18, 158a (1999).

  277. Ewesuedo RB, Iyer L, Koenig A, Das S, Mani S, Vogelzang NJ, Brockstein B, Schilsky RL, Kunkel K, Brenckman W, Ratain MJ. Phase I, pharmacokinetic, and pharmacogenetic study of TAS-103. Proc Am Soc Clin Oncol 18, 164a (1999).

  278. Goh BC, Ratain MJ, Bertucci D, Smith R, Mani S, Vogelzang NJ, Schilsky RL, Hutchison M, Smith M, Averbuch S. Douglass E. Phase I study of ZD9331 on a 5-day short infusion schedule every 3 weeks. Proc Am Soc Clin Oncol 18, 170a (1999).

  279. Shepard DR, Ramirez J, Iyer L, Ratain MJ. Metabolism of SN-38 by CYP3A4 and microsomes from human liver. Proc Am Soc Clin Oncol 18, 176a (1999).

  280. Fleming GF, Meropol NJ, Hollis DR, Rosner GL, Fracasso PM, Sosman JA, Tkaczak L, Levine EG, Rhoades C, Caligicuri MA, Carson WE, Ratain MJ. Phase I trial of recombinant human anti-Her2 monoclonal antibody plus low-dose interleukin-2 in patients with solid tumors. Proc Am Soc Clin Oncol 18, 184a (1999).

  281. Lichtman SM, Egorin M, Rosner G, Miller AA, Rhoades C, Hollis D, Rosen DM, Ratain MJ. Clinical pharmacology of paclitaxel in relation to patient age: CALGB 9762. Proc Am Soc Clin Oncol 18, 190a (1999).

  282. Ratain MJ, Goh BC, Iyer L, Fagbemi S, Mani S, Vogelzang NJ, Schilsky RL, Kunkel K. A phase I study of irinotecan with pharmacokinetic modulation by cyclosporine A and phenobarbital. Proc Am Soc Clin Oncol 18, 202a (1999).

  283. Bertucci D, Mani S, Vogelzang NJ, Stadler WM, Ratain MJ. Phase I trial of continuous infusion 5-fluorouracil and weekly gemcitabine: updated results. Proc Am Soc Clin Oncol 18, 203a (1999).

  284. Daughterty CK, Hlubocky F, Ratain MJ, Banik DM. Assessing advanced cancer patients’ awareness of prognosis: why simply asking may not be measuring. Proc Am Soc Clin Oncol 18, 417a (1999).

  285. Helft PR, Hlubocky F, Gordon EJ, Ratain MJ, Daugherty CK. Hope and awareness of prognosis in advanced cancer patients. J Invest Med 47, 225A (1999).

  286. Hoop J, Tippin D, Levisetti M, Eisenbeis C, Ratain MJ. Vincristine-induced myocardial ischemia. J Invest Med 47, 233A (1999).

  287. Gordon EJ, Hlubocky F, Ratain MJ, Daugherty CK. Advanced cancer patients’ choices regarding experimental therapies: evidence of decisions made prior to the informed consent process. Medical Decision Making, in press (2000).

  288. Daugherty CK, Banik DM, Ratain MJ, Siegler M, Elstein A. Ethics of randomized controlled trials: physician willingness to enroll patients in the absence of individual clinical equipoise. Medical Decision Making, in press (2000).

  289. Daugherty CK, Goh BC, Ratain MJ. The standard phase II trial design is not acceptable to most patients. Proc Am Soc Clin Oncol 19, 208a (2000).

  290. Ryan CW, Janus TJ, Vogelzang NJ, Vokes EE, Kindler HL, Dutta S, Conroy M, Ratain MJ. A phase I study of men and women with refractory malignancies given daily dosing of an endothelin receptor antagonist. Proc Am Soc Clin Oncol 19, 201a (2000).

  291. Hlubocky FJ, Daugherty CK, Banik DM, Ratain MJ, Siegler M. Community equipoise is more important than individual equipoise in referral to randomized controlled trials. Proc Am Soc Clin Oncol 19, 438a (2000).

  292. Jacobs RH, Mauer AM, Fleming GF, Bertucci D, Rotmensch J, Ratain MJ. Phase I study of Doxil, paclitaxel, and cisplatin in patients with advanced solid tumors. Proc Am Soc Clin Oncol 19, 406a (2000).

  293. Sobecks R, Janisch L, Cataland S, Mani S, Daugherty C, Zimmerman T, Ratain M, Larson R. Phase I study of gemcitabine and cladribine in advanced hematogic malignancies. Proc Am Soc Clin Oncol 19,228a (2000).

  294. Schilsky RL, Hausheer FH, Bertucci D, Berghorn EJ, Kindler HL, Ratain MJ. Phase I trial of karenitecin administered intravenously daily for five consecutive days in patients with advanced solid tumors using accelerated dose titration. Proc Am Soc Clin Oncol 19,195a (2000).

  295. Sawyer MB, Ratain MJ, Janisch LA, Smith R, Fleming GF, Schilsky RL, Shulman KL, Vogelzang NJ, DeMario MD, Douglas E. A phase I study of ZD9331 administered orally for up to 28 days every 6 weeks. Proc Am Soc Clin Oncol 19, 236a (2000).

  296. Iyer L, Janisch L, Das S, Ramirez J, Hurley-Buterman CE, DeMario MD, Vokes EE, Kindler HL, Ratain MJ. UGT1A1 promoter genotype correlates with pharmacokinetics of irinotecan (CPT-11). Proc Am Soc Clin Oncol 19, 178a (2000).

  297. Innocenti F, Stadler WM, Iyer L, Vokes EE, Ratain MJ. Flavopiridol-induced diarrhea is related to the systemic metabolism of flavopiridol to its glucuronide. Proc Am Soc Clin Oncol 19, 179a (2000).

  298. DeMario MD, Janisch LA, Vogelzang NJ, Fleming G, Ratain MJ. A phase I study of paclitaxel and irinotecan coadministered weekly in patients with advanced cancers: lymphopenia as a principal toxicity. Proc Am Soc Clin Oncol 19, 229a (2000).

  299. Marshall J, Bhargava P, Kindler HL, Rizvi N, Baidas S, Luhtala T, Boylan S, Ness E, Dordal M, Vogelzang N, Ratain MJ, Hawkins MJ. Phase I study of oral CEP-701, a novel neurotrophin receptor-linked tyrosine kinase inhibitor. Proc Am Soc Clin Oncol 19, 184a (2000).

  300. Helft PR, Hlubocky FJ, Gordon EJ, Ratain MJ, Daugherty CK. Hope and the media in advanced cancer patients. Proc Am Soc Clin Oncol 19, 633a (2000).

  301. Schwartz GN, Schilsky RL, Pendyala L, Berghorn E, Bertucci D, Ratain MJ, Hausheer FH. Phase I trial of escalating doses of BNP7787 in patients receiving paclitaxel and cisplatin. Proc Am Soc Clin Oncol 19, 218a (2000).

  302. Garcia JC, Vogelzang NJ, Cohn HC, Stadler WM, Kugler JW, Troeger T, Giannone E, Arrieta RL, Ratain MJ, Vokes EE. Weekly bolus suramin in hormone refractory prostate cancer: a study from the University of Chicago Phase II Network. Proc Am Soc Clin Oncol 19, 539a (2000).

  303. Dolan ME, Posner MC, Radosta J, Steinberg G, Peabody T, Bertucci D, Vujasin L, Ratain MJ.

  304. Determination of the optimal modulatory dose of O6- benzylguanine in patients with surgically

  305. resectable tumor. Clin Cancer Res 6, 4506s (2000).


Manuscripts in Progress

Iyer L, Ramirez J, Shepard DR, Hossfeld DK, Ratain MJ, Mayer U. Biliary transport of irinotecan and metabolites in normal and P-glycoprotein deficient mice (submitted to Br J Cancer).

Cheung WK, Larson RA, Vogelzang NJ, Mico BA, Moyer M, Skee D, Ratain MJ. Pharmacokinetics of cladribine following escalating intravenous administration to patients with refractory solid tumors and advanced hematologic malignancies (submitted to Cancer Chemother Pharmacol).

Goh BC, Vokes EE, Joshi A, Ratain MJ. Phase I study of the combination of losoxantrone and cyclophosphamide in patients with refractory solid tumors (submitted to Clin Cancer Res).

Mani S, Vogelzang NJ, Bertucci D, Stadler WM, Schilsky RL, Ratain MJ. Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies (submitted to Cancer).

Rosner GL, Stadler W, Ratain MJ. The randomized discontinuation design: application to cytostatic antineoplastic agents (submitted to J Clin Oncol).

Lathia C, Fleming G, Meyer M, Ratain MJ, Whitfield L. Pentostatin pharmacokinetics and dosing guidelines in patients with renal impairment (in preparation).