Colorectal Cancer Clinical Trial
Official title:
Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in
treating patients with metastatic 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.
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