Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00628810
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy together with bevacizumab and to see how well it works in treating patients with metastatic colorectal cancer.
- Detailed Description
OBJECTIVES:
Primary
* Evaluate the objective response (RECIST criteria) at 6 months associated with FOLFIRI and bevacizumab therapy.
* Evaluate the tolerability (NCI CTC v. 2.0 criteria) of this treatment.
Secondary
* Evaluate progression-free survival and overall survival.
* Determine the time to treatment failure.
* Evaluate the quality of life (EuroQOL EQ5D questionnaire).
* Explore the prognostic factors associated with the tolerability and efficacy of this treatment.
OUTLINE: This is a multicenter study. Patients are stratified according to genotype (UCT1A1\*1/ UCT1A1\*1 vs UCT1A1\*1/ UCT1A1\*28).
Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 4 courses, and then every 2 months after the completion of study therapy.
After completion of study therapy, patients are followed every 2-3 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FOLFIRI fort plus bevacizumab bevacizumab Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study. FOLFIRI fort plus bevacizumab fluorouracil Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study. FOLFIRI fort plus bevacizumab irinotecan hydrochloride Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study. FOLFIRI fort plus bevacizumab leucovorin calcium Bevacizumab 5 mg/kg D1, irinotecan 260 mg/m2 D1, LV 400 mg/m2 D1, 5FU 400 mg/m2 IV bolus D1, and 5FU 2,400 mg/m2 46-hour infusion D1-2 every 2 weeks. Treatment was started within 2 weeks after inclusion in the study.
- Primary Outcome Measures
Name Time Method Objective response at 6 months by RECIST 6 months Tolerability evaluated by NCI CTC v. 2.0 criteria From Inclusion
- Secondary Outcome Measures
Name Time Method Progression-free and overall survival From Inclusion Time to treatment failure From Inclusion Quality of life using the EuroQOL EQ5D questionnaire From Inclusion
Trial Locations
- Locations (32)
Hopital Ambroise Pare
🇫🇷Boulogne-Billancourt, France
Hopital Du Bocage
🇫🇷Dijon, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Hopital Duffaut
🇫🇷Avignon, France
Centre Hospitalier Universitaire d'Amiens
🇫🇷Amiens, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier General
🇫🇷Brive, France
Federation Francophone de Cancerologie Digestive
🇫🇷Dijon, France
CHU de Caen
🇫🇷Caen, France
Hopitaux Civils de Colmar
🇫🇷Colmar, France
Clinique Saint Vincent
🇫🇷Epernay, France
Centre Hospitalier de Chalons-en-Champagne
🇫🇷Chalons-en-Champagne, France
Centre Hospitalier Universitaire de Bicetre
🇫🇷Le Kremlin Bicetre, France
CHU Nord
🇫🇷Marseille, France
CHU de la Timone
🇫🇷Marseille, France
Hopital de l'Archet CHU de Nice
🇫🇷Nice, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
CHU - Robert Debre
🇫🇷Reims, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Clinique du Tonkin
🇫🇷Villeurbanne, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Centre Hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Centre Hospitalier d'Abbeville
🇫🇷Abbeville, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Hopital Andre Mignot
🇫🇷Le Chesnay, France
Centre Hospitalier General Lucien Hussel
🇫🇷Vienne, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Clinique Mathilde
🇫🇷Rouen, France
CHRU de Tours - Hopital Trousseau
🇫🇷Tours, France