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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003950 |
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 |
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Colorectal Cancer |
Drug: cyclosporine Drug: irinotecan hydrochloride |
Phase II |
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 |
Estimated Enrollment: | 45 |
Study Start Date: | January 2000 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
Study Chair: | Hedy L. Kindler, MD | University of Chicago |
Study ID Numbers: | CDR0000067145, UCCRC-T98-0049, NCI-T98-0049 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003950 History of Changes |
Health Authority: | United States: Federal Government |
stage IV colon cancer stage IV rectal cancer recurrent colon cancer |
recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
Cyclosporine Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Clotrimazole Miconazole Colonic Diseases Irinotecan Rectal Diseases Cyclosporins Antifungal Agents Digestive System Neoplasms Rectal Neoplasm Tioconazole |
Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Recurrence Camptothecin Rectal Cancer Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Antirheumatic Agents Adenocarcinoma Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Anti-Infective Agents Cyclosporine Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Irinotecan Physiological Effects of Drugs Cyclosporins Rectal Diseases Neoplasms by Site Antifungal Agents Therapeutic Uses |
Dermatologic Agents Digestive System Neoplasms Enzyme Inhibitors Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Camptothecin Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Antirheumatic Agents Antineoplastic Agents, Phytogenic Colorectal Neoplasms |