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Spots Global Cancer Trial Database for Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer

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Trial Identification

Brief Title: Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer

Official Title: Multicenter Phase III Randomized Study of FOLFIRI Plus Bevacizumab Following or Not by a Maintenance Therapy With Bevacizumab in Patients With Non-Pretreated Metastatic Colorectal Cancer

Study ID: NCT00952029

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.

Detailed Description: OBJECTIVES: Primary * Compare disease-control duration in patients with metastatic colorectal cancer receiving FOLFIRI chemotherapy in combination with bevacizumab with or without bevacizumab maintenance therapy. Secondary * Determine objective response rate. * Determine non-hematologic grade 3-4 (except alopecia) toxicity rate. * Determine overall toxicity rate. * Determine duration of chemotherapy-free interval. * Determine progression-free survival. * Determine overall survival. * Determine time-to-treatment failure. * Determine quality of life (EORTC QLQ-C30). * Complete geriatric evaluation. OUTLINE: This is a multicenter study. Patients are stratified according to cancer center, primary tumor (resected vs unresected), and Köhne criteria (low vs intermediate vs high). Patients are randomized to 1 of 2 treatment arms. * Arm A: Patients receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. Chemotherapy treatment repeats every 2 weeks for 12 courses. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks during chemotherapy. Patients then receive bevacizumab maintenance therapy once every 2 weeks during the chemotherapy-free interval. * Arm B: Patients receive FOLFIRI chemotherapy and bevacizumab as in arm A. Patients receive no treatment during the chemotherapy-free interval. In all arms, the chemotherapy treatment and the chemotherapy-free interval treatment repeats in the absence of disease progression during the chemotherapy portion or unacceptable toxicity. Patients who progress during the chemotherapy-free interval will receive 12 more courses of chemotherapy. All patients complete quality of life questionnaires (QLQ-30) and patients ≥ 75 also complete the geriatric questionnaire at baseline and every 8 weeks during study treatment. After completion of study treatment, patients are followed up every 8 weeks.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CH, Abbeville, , France

Centre Radiothérapie et Oncologie de Moyenne Garonne, Agen, , France

CHU, Amiens, , France

Centre Paul Papin, Angers, , France

CHU, Angers, , France

Pringny, Annecy, , France

CH, Aubenas, , France

CH, Auxerre, , France

Polyclinique Sainte Marguerite, Auxerre, , France

CH, Avignon, , France

Ch, Bayonne, , France

CH, Beauvais, , France

CHU, Besançon, , France

Centre Pierre Curie, Beuvry, , France

Ch, Blois, , France

Hôpital Avicenne, Bobigny, , France

Clinique Tivoli, Bordeaux, , France

Institut Bergonié, Bordeaux, , France

CH, Bourg en Bresse, , France

CH, Bourges, , France

CH, Béziers, , France

CH, Cahors, , France

CHIC, Castres, , France

Hôpital Privé Sainte Marie, Chalon sur Saone, , France

CH, Cholet, , France

Clinique des Cèdres, Cornebarrieu, , France

CH, Creteil, , France

CH, Dax, , France

Centre Léonard de Vinci, Dechy, , France

Centre Leclerc, Dijon, , France

CHU, Dijon, , France

Parc, Dijon, , France

CH, Dunkerque, , France

CH, Elbeuf, , France

CH, Frejus, , France

Hôpital Chicas, Gap, , France

CH, La Roche sur Yon, , France

CH, Langres, , France

CH, Le Mans, , France

CH, Libourne, , France

Centre Bourgogne, Lille, , France

Clinique F. Chenieux, Limoges, , France

CH, Longjumeau, , France

CHBS, Lorient, , France

Centre Léon Bérard, Lyon, , France

CHU Edouard Herriot, Lyon, , France

Clinique de la Sauvegarde, Lyon, , France

Clinique Mutualiste, Lyon, , France

Croix Rousse, Lyon, , France

Hôpital Saint Joseph, Lyon, , France

CH, Macon, , France

CHU La Timone, Marseille, , France

Hôpital A. Paré, Marseille, , France

Hôpital Nord, Marseille, , France

Hôpital Saint Joseph, Marseille, , France

CH, Meaux, , France

CHG, Mont de Marsan, , France

CH, Montauban, , France

CH, Montelimar, , France

CH Le Raincy, Montfermeil, , France

Centre Cancérologique, Montpellier, , France

Centre Azuréen, Mougins, , France

Hôpital Saint Herblain, Nantes, , France

Polyclinique, Narbonne, , France

CH, Neuilly sur Seine, , France

Centre Antoine Lacassagne, Nice, , France

L'Archet II, Nice, , France

CHU, Nimes, , France

Clinique Valdegour, Centre ONCOGARD - Institut de Cancérologie du Gard, Nimes, , France

CHR (Oncologie Médicale), Orléans, , France

CHR, Orléans, , France

Clinique Les Murlins, Orléans, , France

Bichat, Paris, , France

CHU - Kremlin Bicêtre, Paris, , France

HEGP, Paris, , France

Hôpital Saint Louis, Paris, , France

Pitié Salpetière, Paris, , France

CH, Pau, , France

CH, Perigueux, , France

CH, Perpignan, , France

CH, Pessac, , France

CH, Rang Du Fliers, , France

CH, Reims, , France

CH, Romans sur Isere, , France

CH, Roubaix, , France

CHU, Rouen, , France

CH, Saint Brieuc, , France

HIA Begin, Saint Mande, , France

Clinique Mutualiste, Saint Nazaire, , France

CHU Saint Etienne, Saint Priest en Jarez, , France

Clinique Armoricaine, Saint-Brieuc, , France

Centre Joliot Curie, Saint-Martin-Boulogne, , France

Centre Paul Strauss, Strasbourg, , France

CHU Trousseau, Tours, , France

CH, Valence, , France

Clinique Générale, Valence, , France

CH, Valenciennes, , France

CAC, Vandoeuvre Les Nancy, , France

CH Bretagne Atlantique, Vannes, , France

Clinique, Vienne, , France

CH, Villejuif, , France

Hôpital Intercommunal, Villeneuve Saint Georges, , France

Contact Details

Name: Thomas Aparicio, Pr

Affiliation: Hopital Avicenne BOBIGNY

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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