Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer
OBJECTIVES: I. Assess the toxicity profile of irinotecan and amifostine when administered
together in patients with metastatic colorectal cancer. II. Assess the total dose of
irinotecan received per 6 week course in these patients. III. Determine the incidence of
irinotecan-induced leukopenia, neutropenia, and diarrhea in these patients. V. Determine the
response rate for this patient population.
OUTLINE: This is an open label study. Amifostine is administered by 10 minute IV infusions.
Irinotecan is administered by IV infusions 15 minutes after completion of amifostine.
Treatment is repeated every 2 weeks for 6 weeks. This 6 week course is repeated in the
absence of disease progression. Treatment may be delayed up to 2 weeks after a course to
allow for recovery from toxic effects. Patients are followed at the end of study and at 30
days after study.
PROJECTED ACCRUAL: There will be 25-30 patients accrued into this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule.
Diane Prager, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Wilshire Oncology Medical Group, Inc.||Rancho Cucamonga, California 91730|