Colorectal Cancer Clinical Trial
Official title:
A Phase II Trial of Irinotecan (CPT-11) and Cyclosporine in Patients With 5-FU Refractory Advanced Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Cyclosporine may relieve the diarrhea caused by irinotecan.
PURPOSE: Phase II trial to study the effectiveness of irinotecan and cyclosporine in
treating patients who have metastatic, advanced, or locally recurrent colorectal cancer that
has not responded to fluorouracil.
OBJECTIVES: I. Determine the response rate of patients with metastatic, advanced, or locally
recurrent fluorouracil refractory adenocarcinoma of the colon or rectum treated with
irinotecan and cyclosporine. II. Determine antitumor activity, safety, tolerance, and
toxicity of this combination treatment in these patients.
OUTLINE: This is a multicenter study. Patients receive cyclosporine IV over 6 hours and
irinotecan IV over 90 minutes weekly for 4 weeks. Courses repeat every 6 weeks. Patients
receive at least 2 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 15-45 patients will be accrued for this study over 14 months.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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