Irinotecan: Toward clinical end points in drug development

ONCOLOGY

Volumn 12, Issue 8 SUPPL., 1998, Pages 13-21

  Pazdur, Richard ^a  

^a UNIVERSITY OF TEXAS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOEMBRYONIC ANTIGEN; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; LOPERAMIDE;

ANTINEOPLASTIC ACTIVITY; ASTHENIA; CANCER CHEMOTHERAPY; CLINICAL TRIAL; COLORECTAL CANCER; CONFERENCE PAPER; DIARRHEA; DRUG TOLERABILITY; FEVER; FOLLOW UP; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MUCOSA INFLAMMATION; NEUTROPENIA; OUTCOMES RESEARCH; QUALITY OF LIFE; RASH; SURVIVAL TIME; VOMITING;

ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS, PHYTOGENIC; CAMPTOTHECIN; CLINICAL TRIALS, PHASE III; COLORECTAL NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS;

EID: 0031773305     PISSN: 08909091     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (15)

1. Advanced Colorectal Cancer Meta-Analysis Project: Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: Evidence in terms of response rate. J Clin Oncol 10:896-903, 1992.
2. Von Hoff DD, Rothenberg ML, Pitot HC, et al: Irinotecan (CPT-11) therapy for patients with previously treated metastatic colorectal cancer: Overall results of FDA-reviewed pivotal US clinical trials (abstract) Proc Am Soc Clin Oncol 16:228a, 1997.
3. Rothenberg ML, Eckardt JR, Kuhn JG, et al: Phase II trial of irinotecan in patients with progressive or rapidly recurrent colorectal cancer. J Clin Oncol 14:1128-1135, 1996.
4. Pitot HC, Wender DB, O'Connell MJ, et al: Phase II study of irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 15:2910-2919, 1997.
5. Shimada Y, Yoshino M, Wakui A, et al: Phase II study of CPT-11, a new camptothecin derivative, in metastatic colorectal cancer. J Clin Oncol 11:909-913, 1993.
6. Rougier P, Bugat R, Douillard JY, et al: 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.
7. Cunningham D, Pyrhonen S, James RD, et al: A phase III multicenter randomized study of CPT-11 vs supportive care alone in patients with 5FU-resistant metastatic colorectal cancer (abstract). Proc Am Soc Clin Oncol 17:1a, 1998.
8. Van Cutsem E, Bajetta E, Niederle N, et al: A phase III multicenter randomized trial comparing CPT-11 to infusional 5-FU regimen in patients with advanced colorectal cancer after 5-FU failure (abstract). Proc Am Soc Clin Oncol 17:256a, 1998.
9. Blijham GH, Mesbah M, Glimelius B, et al: Quality of life (QOL) evaluation of CPT-11 compared to best supportive care or infusional 5-FU in patients with 5-FU resistant advanced colorectal cancer (abstract). Proc Am Soc Clin Oncol 17:413a, 1998.
10. de Gramont A, Bosset JF, Milan C, et al: Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: A French intergroup study. J Clin Oncol 15(2):808-815, 1997.
11. Lokich JJ, Ahlgren JD, Gullo JJ, et al: A prospective randomized comparison of continuous fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: A Mid-Atlantic Oncology Program Study. J Clin Oncol 11:1888-1893, 1993.
12. Köhne CH, Schöfski P, Wilke H, et al: Biochemical modulation of weekly high-dose infusional (HD-CI) 5-FU in patients with advanced colorectal cancer. Results of a multicenter randomized AIO trial (abstract) Am Soc Clin Oncol 16:271a, 1997.
13. Abigerges D, Chabot GG, Armand J-P, et al: Phase I and pharmacokinetic studies of camptothecin analog irinotecan administered every 3 weeks in cancer patients. J Clin Oncol 13:210-21, 1995
14. Armand J-P, Ducreux M, Mahjoubi M, et al: CPT-11 in the treatment of colorectal cancer. Eur J Cancer 31:1283-87, 1995.
15. Pazdur R, Zinner R, Rothenberg ML, et al: Age as a risk factor in irinotecan treatment of 5-FU refractory colorectal cancer (abstract). Proc Am Soc Clin Oncol 16:260a, 1997.