Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer
RATIONALE: Octreotide may be effective in preventing diarrhea that is caused by treatment with irinotecan.
PURPOSE: Randomized phase III trial to study the effectiveness of octreotide in preventing diarrhea in patients who are receiving irinotecan for metastatic colon cancer.
Drug: irinotecan hydrochloride
Drug: octreotide acetate
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Prospective, Randomized Trial of Sandostatin LAR Depot for the Prevention of Irinotecan-Induced Diarrhea in Patients With Metastatic Colorectal Cancer|
|Study Start Date:||December 1999|
|Primary Completion Date:||December 1999 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare the incidence of grade 2-4 diarrhea after completion of irinotecan in patients with metastatic colorectal cancer treated with octreotide vs placebo. II. Compare the duration of diarrhea and need for irinotecan dose reduction/ delay and hospitalization in patients treated with these 2 regimens. III. Collect data on tumor response and 1 year survival in patients treated with these 2 regimens. IV. Determine the pharmacokinetics and interaction of irinotecan and octreotide in a subset of these patients.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to prior pelvic irradiation (yes vs no), age (under 70 vs 70 and over), and ECOG performance status (0 vs 1 or 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive octreotide intramuscularly (IM) once. Beginning 10-14 days later, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive octreotide IM on the same day as irinotecan. Arm II: Patients receive placebo IM once. Beginning 10-14 days later, patients receive irinotecan as in arm I. Patients also receive placebo IM on the same day as irinotecan. Therapy continues every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 1.
PROJECTED ACCRUAL: A total of 300 patients (150 per arm) will be accrued for this study.
|United States, New Jersey|
|Novartis Pharmaceuticals Corporation|
|East Hanover, New Jersey, United States, 07936|
|Princeton, New Jersey, United States, 08543|
|Study Chair:||Kurt Sizer, MD||Novartis Pharmaceuticals|