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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003950
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: cyclosporine
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Irinotecan    Irinotecan hydrochloride    Cyclosporin    Cyclosporine    Fluorouracil   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Irinotecan (CPT-11) and Cyclosporine in Patients With 5-FU Refractory Advanced Colorectal Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   45
Study Start Date:   January 2000

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003950

Locations
United States, Illinois
Cancer Care Specialists of Central Illinois, S.C.    
      Decatur, Illinois, United States, 62526
Central Illinois Hematology Oncology Center    
      Springfield, Illinois, United States, 62701
Division of Hematology/Oncology    
      Park Ridge, Illinois, United States, 60068
Evanston Northwestern Health Care    
      Evanston, Illinois, United States, 60201
Louis A. Weiss Memorial Hospital    
      Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.    
      Peoria, Illinois, United States, 61602
University of Chicago Cancer Research Center    
      Chicago, Illinois, United States, 60637
University of Illinois at Chicago    
      Chicago, Illinois, United States, 60612
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

Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)

Investigators
Study Chair:     Hedy L. Kindler, MD     University of Chicago    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067145, UCCRC-T98-0049, NCI-T98-0049
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003950
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer  
stage IV rectal cancer  
recurrent colon cancer  
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

Study placed in the following topic categories:
Digestive System Neoplasms
Cyclosporine
Clotrimazole
Gastrointestinal Diseases
Miconazole
Irinotecan
Colonic Diseases
Tioconazole
Intestinal Diseases
Cyclosporins
Rectal Diseases
Camptothecin
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2008




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