The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
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
Study ID: NCT00628810
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Hospitalier d'Abbeville, Abbeville, , France
Centre Hospitalier Universitaire d'Amiens, Amiens, , France
Hopital Duffaut, Avignon, , France
C.H.G. Beauvais, Beauvais, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Hopital Ambroise Pare, Boulogne-Billancourt, , France
Centre Hospitalier Pierre Oudot, Bourgoin-Jallieu, , France
Centre Hospitalier General, Brive, , France
CHU de Caen, Caen, , France
Centre Regional Francois Baclesse, Caen, , France
Centre Hospitalier de Chalons-en-Champagne, Chalons-en-Champagne, , France
Hopitaux Civils de Colmar, Colmar, , France
Hopital Du Bocage, Dijon, , France
Federation Francophone de Cancerologie Digestive, Dijon, , France
Clinique Saint Vincent, Epernay, , France
Centre Hospitalier Departemental, La Roche Sur Yon, , France
Hopital Andre Mignot, Le Chesnay, , France
Centre Hospitalier Universitaire de Bicetre, Le Kremlin Bicetre, , France
CHU de la Timone, Marseille, , France
CHU Nord, 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
Hopital Bichat - Claude Bernard, Paris, , France
CHU - Robert Debre, Reims, , France
Hopital Charles Nicolle, Rouen, , France
Clinique Mathilde, Rouen, , France
Clinique Armoricaine De Radiologie, Saint Brieuc, , France
CHRU de Tours - Hopital Trousseau, Tours, , France
Centre Hospitalier General Lucien Hussel, Vienne, , France
Clinique du Tonkin, Villeurbanne, , France
Name: Martina Schneider
Affiliation: Federation Francophone de Cancerologie Digestive
Role: STUDY_CHAIR