Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00006115|
Recruitment Status : Unknown
Verified January 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 8, 2004
Last Update Posted : January 13, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: FOLFIRI regimen Drug: FOLFOX regimen Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Drug: oxaliplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Alternation of FOLFOX6 (Oxaliplatin - Leucovorin - Fluorouracil) and FOLFIRI (Irinotecan - Leucovorin - Fluorouracil) as Second Line Treatment of Metastatic Colorectal Cancer|
|Study Start Date :||April 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006115
|Dijon, France, 21000|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59000|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Meulan, France, 78250|
|Montfermeil, France, 93370|
|Centre Hospitalier de Mulhouse|
|Mulhouse, France, 68051|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Hopital Bichat-Claude Bernard|
|Paris, France, 75018|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75651|
|Paris, France, 75970|
|Hopital Claude Gallien|
|Quincy Sous Senart, France, 91480|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Senlis, France, 60300|
|Clinique de l'Orangerie|
|Strasbourg, France, 67010|
|Study Chair:||Mohamed Hebbar, MD||Centre Hospital Universitaire Hop Huriez|