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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic, advanced, or locally recurrent
fluorouracil (5-FU) refractory adenocarcinoma of the colon or rectum Progression of
disease within 6 months of receiving adjuvant 5-FU based chemotherapy OR Progression of
disease during or following completion of 5-FU based chemotherapy for metastatic disease
No more than 1 failure with a 5-FU regimen for recurrent, advanced, or metastatic disease
Failure on 5-FU adjuvant therapy must accompany failure on 5-FU therapy for metastatic
disease Bidimensionally measurable disease CNS metastases allowed only with measurable
disease in other sites Prior treatment for CNS metastases required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3500/mm3 Absolute neutrophil count at least
1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
AST and ALT no greater than 3 times upper limit of normal Renal: Creatinine no greater
than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: No other significant,
uncontrolled underlying medical or psychiatric condition No serious active infection Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception Neurologically stable No other prior malignancy within past 5 years except
curatively treated nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics Prior adjuvant fluorouracil (5-FU) allowed No more than 2 prior
5-FU regimens (no more than 1 for recurrent or metastatic disease) No other concurrent
chemotherapy Endocrine therapy: No concurrent hormonal therapy (except contraceptives or
replacement steroids) No concurrent IV steroids Radiotherapy: Prior radiotherapy allowed
if measurable disease outside radiation port At least 4 weeks since prior radiotherapy and
recovered No concurrent radiotherapy Surgery: Not specified Other: No concurrent
anticonvulsant therapy No other concurrent experimental medications

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Reduction in occurrences of severe diarrhea due to CPT-11 administration

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

January 2005

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



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