Octreotide in the Prevention of Diarrhea in Patients Receiving Irinotecan for Metastatic Colon Cancer

Phase 3

Terminated

• Conditions: Colorectal Cancer; Diarrhea

• Registration Number: NCT00006269
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1999-12
• Primary Completion: 1999-12
• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2004-05-21
• Study First Posted: 2004-05-24
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Novartis Pharmaceuticals Corporation; 🇺🇸 East Hanover, New Jersey, United States

Theradex; 🇺🇸 Princeton, New Jersey, United States