Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00006115
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.
- Detailed Description
OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer. II. Evaluate these treatment regimens in terms of overall survival, response rate, toxicity, and quality of life in this patient population.
OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Hopital Tenon
🇫🇷Paris, France
Hopital Claude Gallien
🇫🇷Quincy Sous Senart, France
Hopital Saint Antoine
🇫🇷Paris, France
CHU Pitie-Salpetriere
🇫🇷Paris, France
Hopital Drevon
🇫🇷Dijon, France
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
Centre Jean Bernard
🇫🇷Le Mans, France
CH Meulan
🇫🇷Meulan, France
Intercommunal Hospital
🇫🇷Montfermeil, France
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Clinique Saint Jean
🇫🇷Lyon, France
American Hospital of Paris
🇫🇷Neuilly Sur Seine, France
Hopital Bichat-Claude Bernard
🇫🇷Paris, France
Polyclinique De Courlancy
🇫🇷Reims, France
C.H. Senlis
🇫🇷Senlis, France
Clinique de l'Orangerie
🇫🇷Strasbourg, France