Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
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.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Chemotherapy With FOLFIRI Plus Bevacizumab (AvastinR) in Patients With Metastatic Colorectal Cancer Bearing Genotype UGT1A1*1/UGT1A1*1 or UGT1A1*1/UGT1A1*1/UGT1A1*28: Prospective, Phase II, Multicenter Study|
- Objective response at 6 months by RECIST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Tolerability evaluated by NCI CTC v. 2.0 criteria [ Time Frame: From Inclusion ] [ Designated as safety issue: Yes ]
- Progression-free and overall survival [ Time Frame: From Inclusion ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: From Inclusion ] [ Designated as safety issue: No ]
- Quality of life using the EuroQOL EQ5D questionnaire [ Time Frame: From Inclusion ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Experimental: FOLFIRI fort plus 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.
|Biological: bevacizumab Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628810
|Centre Hospitalier d'Abbeville|
|Abbeville, France, 80101|
|Centre Hospitalier Universitaire d'Amiens|
|Amiens, France, 80054|
|Avignon, France, 84902|
|Beauvais, France, 60021|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Polyclinique Bordeaux Nord Aquitaine|
|Bordeaux, France, 33300|
|Hopital Ambroise Pare|
|Boulogne-Billancourt, France, F-92104|
|Centre Hospitalier Pierre Oudot|
|Bourgoin-Jallieu, France, 38300|
|Centre Hospitalier General|
|Brive, France, 19101|
|CHU de Caen|
|Caen, France, 14033|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Hospitalier de Chalons-en-Champagne|
|Chalons-en-Champagne, France, 51000|
|Hopitaux Civils de Colmar|
|Colmar, France, 68024|
|Hopital Du Bocage|
|Dijon, France, 21034|
|Federation Francophone de Cancerologie Digestive|
|Dijon, France, 21079|
|Clinique Saint Vincent|
|Epernay, France, 51200|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, F-85025|
|Hopital Andre Mignot|
|Le Chesnay, France, 78157|
|Centre Hospitalier Universitaire de Bicetre|
|Le Kremlin Bicetre, France, 94275|
|CHU de la Timone|
|Marseille, France, 13385|
|Marseille, France, 13915|
|Hopital de l'Archet CHU de Nice|
|Nice, France, F-06202|
|CHR D'Orleans - Hopital de la Source|
|Orleans, France, 45100|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|CHU - Robert Debre|
|Reims, France, 51092|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Rouen, France, 76100|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|CHRU de Tours - Hopital Trousseau|
|Tours, France, 37044|
|Centre Hospitalier General Lucien Hussel|
|Vienne, France, 38200|
|Clinique du Tonkin|
|Villeurbanne, France, 69100|
|Study Chair:||Martina Schneider||Federation Francophone de Cancerologie Digestive|