A Phase II Trial of Irinotecan (CPT-11) and Cyclosporine in Patients With 5-FU Refractory Advanced Colorectal Cancer
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
Reduction in occurrences of severe diarrhea due to CPT-11 administration
Hedy L. Kindler, MD
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Evanston Northwestern Health Care||Evanston, Illinois 60201|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Cancer Care Specialists of Central Illinois, S.C.||Decatur, Illinois 62526|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|
|Michiana Hematology/Oncology P.C.||South Bend, Indiana 46617|
|Division of Hematology/Oncology||Park Ridge, Illinois 60068|