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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
N/A
Not Enrolling
Both
Colorectal Cancer

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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:

Interventional

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:

Yes

Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9824

NCT ID:

NCT00003950

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Evanston Northwestern Health CareEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
University of Illinois at ChicagoChicago, 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 CenterSpringfield, 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/OncologyPark Ridge, Illinois  60068