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Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer Clinical research trials and Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer. Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer clinical trial. Human subjects often get the best healthcare available for their Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer  Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
For Condition: adenocarcinoma of the rectum,recurrent colon cancer,recurrent rectal cancer,adenocarcinoma of the colon,Stage 4 rectal cancer,stage 4 colon cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HedyKindler, Study Chair, University of Chicago Cancer Research Center
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, 61602
United States
Cancer Care Specialists of Central Illinois, S.C.
Decatur, Illinois, 62526
United States
University of Illinois at Chicago
Chicago, Illinois, 60612
United States
Michiana Hematology/Oncology P.C.
South Bend, Indiana, 46617
United States
Division of Hematology/Oncology
Park Ridge, Illinois, 60068
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Fort Wayne Medical Oncology and Hematology, Inc.
Ft. Wayne, Indiana, 46885-5099
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 62701
United States
Evanston Northwestern Health Care
Evanston, Illinois, 60201
United States
Additional Information:
Study ID Numbers: CDR0000067145; UCCRC-T98-0049,NCI-T98-0049
Study Start Date: January 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003950
Other Recurrent Colon Cancer Studies:
1. SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
2. Imatinib Mesylate in Treating Patients With Stage IV Colorectal Cancer
3. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Colorectal Cancer
5. Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
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Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
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