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A Phase II Trial of Irinotecan (CPT-11) and Cyclosporine in Patients With 5-FU Refractory Advanced Colorectal Cancer (NCT00003950)

National Cancer Institute (NCI)
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.
  • Drug: cyclosporine
    • Sandimmune®, Restatis®
  • Drug: CPT-11
    • Irinotecan, Camptosar®
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.

10 locations

United States (10)
  • University of Illinois at Chicago
    Not specified
    Chicago, Illinois, United States, 60612
  • University of Chicago Cancer Research Center
    Not specified
    Chicago, Illinois, United States, 60637
  • Louis A. Weiss Memorial Hospital
    Not specified
    Chicago, Illinois, United States, 60640
  • Cancer Care Specialists of Central Illinois, S.C.
    Not specified
    Decatur, Illinois, United States, 62526
  • Evanston Northwestern Health Care
    Not specified
    Evanston, Illinois, United States, 60201
  • Division of Hematology/Oncology
    Not specified
    Park Ridge, Illinois, United States, 60068
  • Oncology/Hematology Associates of Central Illinois, P.C.
    Not specified
    Peoria, Illinois, United States, 61602
  • Central Illinois Hematology Oncology Center
    Not specified
    Springfield, Illinois, United States, 62701
  • Fort Wayne Medical Oncology and Hematology, Inc.
    Not specified
    Fort Wayne, Indiana, United States, 46885-5099
  • Michiana Hematology/Oncology P.C.
    Not specified
    South Bend, Indiana, United States, 46617
31 December, 1999
05 March, 2014
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