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 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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Thomas Aparicio, Pr
Affiliation: Hopital Avicenne BOBIGNY
Role: PRINCIPAL_INVESTIGATOR