Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00006269|
Recruitment Status : Terminated
First Posted : May 24, 2004
Last Update Posted : May 25, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Diarrhea||Drug: irinotecan hydrochloride Drug: octreotide acetate||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|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|
|Actual Primary Completion Date :||December 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006269
|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|