Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent 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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Irinotecan (CPT-11) and Cyclosporine in Patients With 5-FU Refractory Advanced Colorectal Cancer|
- Reduction in occurrences of severe diarrhea due to CPT-11 administration [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2000|
|Study Completion Date:||January 2005|
|Primary Completion Date:||December 2001 (Final data collection date for primary outcome measure)|
Experimental: CPT-11 with Cyclosporine
Each cycle lasts 6 weeks. Administration of cyclosporine and CPT-11 weekly for 4 weeks followed by a 2 week 'rest' period with no drug given. Cyclosporine is given by IV infusion at a dose of 5 mg/kg. CPT-11 is given by IV infusion at a dose of 60 mg/m2.
Other Name: Sandimmune®, Restatis®Drug: CPT-11
Other Name: Irinotecan, Camptosar®
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003950
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|Cancer Care Specialists of Central Illinois, S.C.|
|Decatur, Illinois, United States, 62526|
|Evanston Northwestern Health Care|
|Evanston, Illinois, United States, 60201|
|Division of Hematology/Oncology|
|Park Ridge, Illinois, United States, 60068|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|Central Illinois Hematology Oncology Center|
|Springfield, Illinois, United States, 62701|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Michiana Hematology/Oncology P.C.|
|South Bend, Indiana, United States, 46617|
|Study Chair:||Hedy L. Kindler, MD||University of Chicago|