Results of a European Organization for Research and Treatment of Cancer/early clinical studies group phase II trial of first-line irinotecan in patients with advanced or recurrent squamous cell carcinoma of the cervix

Journal of Clinical Oncology

Volumn 17, Issue 10, 1999, Pages 3136-3142

  Lhommé, Catherine ^a   Fumoleau, Pierre ^a   Fargeot, Pierre ^a   Krakowski, Yvan ^a   Dieras, Véronique ^a   Chauvergne, Jacques ^a   Vennin, Philippe ^a   Rebattu, Paul ^a   Roche, Henry ^a   Misset, Jean Louis ^a   Lentz, Marie Ange ^a   Van Glabbeke, Martine ^a   Matthieu Boué, Anne ^a   Mignard, Dominique ^a   Chevallier, Bernard ^a  

^a EORTC DATA CENTER   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER RECURRENCE; CANCER SURVIVAL; CLINICAL TRIAL; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG TOLERABILITY; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SQUAMOUS CELL CARCINOMA; UTERINE CERVIX CARCINOMA;

EID: 0032887487     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1999.17.10.3136     Document Type: Article

References (34)

1. Omura GA: Chemotherapy for cervix cancer. Semin Oncol 21:54-62, 1994
2. Thigpen JT, Vance R, Puneky L, et al: Chemotherapy as a palliative treatment in carcinoma of the uterine cervix. Semin Oncol 22:16-24, 1995 (2 suppl 3)
3. Kanzawa F, Sugimoto Y, Minato K, et al: Establishment of a camptothecine analogue (CPT-11) resistant cell line of human non small cell lung cancer: Characterization and mechanism of resistance. Cancer Res 50:5919-5924, 1990
4. Wall ME, Want MC, Cook CE, et al: Plant antitumour agents: I. The isolation and structure of camptothecin, a novel alkaloidal leukemia and tumor inhibitor from Camptotheca acuminata. J Am Chem Soc 88:3888-3890, 1996
5. Kohn KW, Ewing RAG, Erickson LC, et al: Measurement of strand breaks and cross links by alkaline elution, in Friedberg EC, Hanawalt PC (eds): DNA Repair: A Laboratory Manual of Research Techniques. New York, NY, Marcel Dekker, 1981, pp 379-401
6. Kubota N, Kanzawa F, Nishio K, et al: Detection of topoisomerase I gene point mutation in CPT-11 resistant lung cancer cell line. Biochem Biophys Res Commun 188:571-577, 1992
7. Rowinsky EK, Grochow LB, Ettinger DS, et al: Phase I and pharmacological study of the novel topoisomerase I inhibitor 7-ethyl-10-(4(1-piperidino)-1piperidino)carbonyloxy camptothecin (CPT11) administered as ninety-minute infusion every 3 weeks. Cancer Res 54:427-436, 1994
8. Tsuruo T, Masuzaki T, Matsushita M, et al: Antitumour effect of CPT-11, a new derivative of camptothecine, against pleiotropic drug resistant tumours in vitro and in vivo. Cancer Chemother Pharmacol 21:71-74, 1988
9. Rougier P, Bugat R, Douillard JY, et al: A phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil based chemotherapy. J Clin Oncol 15:251-260, 1997
10. Abigerges D, Chabot GG, Armand JP, et al: Phase I and pharmacologic studies of the camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 13:210-221, 1995
11. Negoro S, Fukuoka M, Masuda N, et al: Phase I study of weekly intravenous infusions of CPT-11, a new derivative of camptothecin, in the treatment of advanced non-small-cell lung cancer. J Natl Cancer Inst 83:1164-1168, 1991
12. Rothenberg ML, Kuhn JG, Burris HA III, et al: Phase I and pharmacokinetic trial of weekly CPT11. J Clin Oncol 11:2194-2204, 1993
13. De Forni M, Bugat R, Chabot GG, et al: Phase I and pharmacokinetic study of the camptothecin derivative irinotecan, administered on a weekly schedule in cancer patients. Cancer Res 54:4347-4354, 1994
14. Suminaga M, Furue H, Taguchi T, et al: Phase I study of CPT11, a derivative of camptothecin. Presented at 16th Int Congress Chemotherapy (ICC), Jerusalem, Israel, June 11-16 1989 (abstr p 51)
15. Takeuchi S, Noda K, Yakushiji M: Late phase II study of CPT 11, a topoisomerase I inhibitor, in advanced cervical carcinoma. Proc Am Soc Clin Oncol 11:224, 1992 (abstr 708)
16. National Cancer Institute: Guidelines for the Reporting of Adverse Drug Reactions. Bethesda, MD, Division of Cancer Treatment, National Cancer Institute, 1988
17. Miller AB, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 47:207-214, 1981
18. Kaplan EL, Meier P: Non-parametric estimation from incomplete data. J Am Stat Assoc 53:457-481, 1958
19. Gehan EA: The determination of the number of patients required in a preliminary and follow-up trial of a new chemotherapeutic agent. J Chronic Dis 13:346-353, 1961
20. Alberts DS, Kronmal R, Baker LH, et al: Phase II randomized trial of cisplatin chemotherapy regimens in the treatment of recurrent or metastatic squamous cell cancer of the cervix: A Southwest Oncology Group study. J Clin Oncol 5:1791-1795, 1987
21. Alberts DS, Garcia D, Mason-Liddil N, et al: Cisplatin in advanced cancer of the cervix: An update. Semin Oncol 1:1811-1824, 1991 (suppl 3)
22. McGuire WP, Blessing JA, Moore D, et al: Paclitaxel has moderate activity in squamous cervix cancer: A Gynecologic Oncology Group study. J Clin Oncol 14:792-795, 1996
23. Kudelka AP, Winn R, Edwards CL, et al: An update of a phase II study of paclitaxel in advanced or recurrent squamous cell cancer of the cervix. Anticancer Drugs 8:657-661, 1997
24. Morris M, Brader KR, Levenback C, et al: Phase II study of vinorelbine in advanced and recurrent squamous cell carcinoma of the cervix. J Clin Oncol 16:1094-1098, 1998
25. Verschraegen CF, Levy T, Kudelka AP, et al: Phase II study of irinotecan in prior chemotherapy-treated squamous cell carcinoma of the cervix. J Clin Oncol 15:625-631, 1997
26. Look KY, Blessing JA, Levenback C, et al: A phase II trial of CPT-11 in recurrent squamous carcinoma of the cervix: A Gynecologic Oncology Group study. Gynecol Oncol 70:334-338, 1998
27. Irvin WP, Price FV, Bailey H, et al: A phase II study of irinotecan (CPT-11) in patients with advanced squamous cell carcinoma of the cervix. Cancer 82:328-333, 1998
28. Brader KR, Morris M, Levenback C, et al: Chemotherapy for cervical carcinoma: Factors determining response and implications for clinical trial design. J Clin Oncol 16:1879-1884, 1998
29. Kaern J, Trope C, Abeler V, et al: A phase II study of 5-fluorouracil/cisplatinum in recurrent cervical cancer. Acta Oncol 29:25-28, 1990
30. Rothenberg ML: CPT-11: An original spectrum of clinical activity. Semin Oncol 23:21-26, 1996 (1 suppl 3)
31. Vermorken JB, Zanetta G, De Oliviera CF, et al: Cisplatin-based combination chemotherapy (BEMP) versus single agent cisplatin (P) in disseminated squamous-cell carcinoma of the uterine cervix (SCUCC): Mature data EORTC protocol 55863. Ann Oncol 7:67, 1996 (suppl 5, abstr 318)
32. Kano Y, Suzuki K, Akutsu M, et al: Effects of CPT-11 in combination with other anti-cancer agents in culture. Int J Cancer 50:604-610, 1992
33. Fushiki H, Hidaka T, Hori S, et al: Evaluation of a new anti-cancer drug regimen against uterine cervical cancer in nude mice [in Japanese]. Gan To Kagaku Ryoho 24:1981-1985, 1997
34. Sugiyama T, Noda K, Yakushiji M, et al: Multicentric phase II trial of irinotecan (CPT-11) and cisplatin as first line chemotherapy in recurrent or advanced cervical cancer: Japan CPT-11 study group trial. Proc Am Soc Clin Oncol 17:352, 1998 (abstr 1360)