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.
Interventional
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.
12 weeks
Yes
Diane Prager, MD
Study Chair
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000066087
NCT00003225
July 1997
June 2001
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Wilshire Oncology Medical Group, Inc. | Rancho Cucamonga, California 91730 |