A Prospective, Randomized Trial of Sandostatin LAR Depot for the Prevention of Irinotecan-Induced Diarrhea in Patients With Metastatic Colorectal Cancer
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.
Primary Purpose: Supportive Care
Kurt Sizer, MD
United States: Food and Drug Administration
|Novartis Pharmaceuticals Corporation||East Hanover, New Jersey 07936|
|Theradex||Princeton, New Jersey 08543|