Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00003950

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: cyclosporine Drug: CPT-11	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2000

Actual Primary Completion Date :

Dec 1, 2001

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: cyclosporine Other Names: Sandimmune®, Restatis® Drug: CPT-11 Other Names: Irinotecan, Camptosar®

Arm

Intervention/Treatment

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.

Drug: cyclosporine

Other Names:

Sandimmune®, Restatis®

Drug: CPT-11

Other Names:

Irinotecan, Camptosar®

Outcome Measures

Primary Outcome Measures

Reduction in occurrences of severe diarrhea due to CPT-11 administration [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
3	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
4	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois	United States	62526
5	Evanston Northwestern Health Care	Evanston	Illinois	United States	60201
6	Division of Hematology/Oncology	Park Ridge	Illinois	United States	60068
7	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61602
8	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
9	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46885-5099
10	Michiana Hematology/Oncology P.C.	South Bend	Indiana	United States	46617