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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer Clinical research trials and Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer. Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer  Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
For Condition: stage 3 colon cancer,stage 3 rectal cancer,adenocarcinoma of the rectum,adenocarcinoma of the colon
Status: No longer recruiting
Sponsor(s): Rhone-Poulenc Rorer ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colorectal cancer.
Details: OBJECTIVES: I. Compare the disease-free survival at 3 years of patients with resected stage III colorectal cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan. II. Compare the disease-free and overall survival at 5 years of patients treated with these regimens. III. Compare the safety profiles of these treatment regimens in these patients. IV. Compare the quality-adjusted survival of patients treated with these regimens. V. Correlate the expression of putative prognostic markers (thymidylate synthase, telomerase, topoisomerase) with disease-free and overall survival of patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive irinotecan IV over 30-90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 24 hours weekly for 6 weeks. Courses repeat every 7 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. As an alternative schedule, patients may receive irinotecan IV over 30-90 minutes and day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 every 2 weeks for 6 weeks. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive leucovorin calcium and fluorouracil as in arm I. Quality of life may be assessed at baseline; prior to courses 2, 3, and 4; and at 1, 3, and 6 months. Patients are followed every 3 months for 3 years and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 1800 patients (900 per arm) will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed adenocarcinoma of the colon or intraperitoneal rectum - Stage III - Completely resected within the past 3-8 weeks (No gross or microscopic evidence of residual disease after surgery) No rectal cancer requiring total meso-rectal resection or pre- or postoperative radiotherapy No prior curatively resected synchronous metastasis of colorectal cancer --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior antineoplastic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: - See Disease Characteristics - No prior celioscopic resection of primary tumor Other: - At least 30 days since prior participation in another clinical trial with any investigational drug - No other concurrent experimental drugs - No other concurrent anticancer therapy --Patient Characteristics-- Age: 18 to 75 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: - Absolute neutrophil count at least 2,000/mm3 - Platelet count at least 150,000/mm3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Alkaline phosphatase no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No myocardial infarction with the past year - No uncontrolled hypertension - No high-risk uncontrolled arrhythmia - No unstable angina pectoris Other: - HIV negative - No chronic diarrhea - No current chronic inflammation or subobstruction of bowel after surgery - No active uncontrolled infection - No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix - No psychological, social, familial, or geographical condition that would preclude follow-up - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricCutsem, Study Chair, Rhone-Poulenc Rorer
CHU Pitie-Salpetriere
Paris, , 75651
France
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Instituto Portugues de Oncologia do Porto
Porto, , 4200
Portugal
Hopital Cantonal Universitaire de Geneva
Geneva, , CH-1211
Switzerland
Universitats-Krankenhaus Eppendorf
Hamburg, , D-20246
Germany
Allgemeines Krankenhaus der Stadt Wien
Vienna (Wien), , A-1090
Austria
Ospedali Riuniti di Bergamo
Bergamo, , 24100
Italy
Ospedale San Carlo Borromeo
Milano (Milan), , 20153
Italy
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Hopital Tenon
Paris, , 75970
France
Hospital Universarito "Reina Sofia"
Cordoba, , 14004
Spain
Azienda Ospedaliera S. Maria
Terni, , 05100
Italy
Universita Degli Studi di Firenze - Policlin. di Careggi
Firenze (Florence), , 1 (50-134)
Italy
National Cancer Institute of Egypt
Cairo, ,
Egypt
Universita Degli Studi di Udine
Udine, , 33100
Italy
Additional Information:
Study ID Numbers: CDR0000069014; EORTC-40993,RP-64174-V-307,PETACC-3
Study Start Date: January 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026273
Other Stage 3 Colon Cancer Studies:
1. BMS-247550 in Treating Patients With Recurrent or Metastatic Colorectal Cancer
2. Combination Chemotherapy With or Without Celecoxib in Treating Patients With Metastatic Colorectal Cancer
3. Fluorouracil and Leucovorin Plus Either Irinotecan or Oxaliplatin With or Without Cetuximab in Treating Patients With Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum
4. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Unresectable Metastatic Colorectal Cancer
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Fluorouracil and Leucovorin With or Without Irinotecan in Treating Patients Following Surgery for Stage III Colorectal Cancer
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