Spots Global Cancer Trial Database for Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)
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Trial Identification
Brief Title: Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)
Official Title: Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2
Study ID: NCT00265824
Conditions
Study Description
Brief Summary: PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
Detailed Description: OBJECTIVES: Primary * Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer. Secondary * Compare the duration of disease control and overall survival of patients treated with these regimens. * Compare the tolerability of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. * Compare the occurrence of secondary surgery in patients treated with these regimens. * Compare the chemotherapy-free intervals and response rates in patients treated with these regimens. INDUCTION THERAPY Bevacizumab IV over 30-90 minutes on day 1, combined with either: * modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil), * XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8), * FOLFIRI (IV : irinotecan, folinic acid, fluorouracil). Treatment repeats every 2 weeks. RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy with bevacizumab alone or bevacizumab+erlotinib MAINTENANCE THERAPY * Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1 * Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib once daily on days 1-21. In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. ACCRUAL: A total of 700 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
LKH Leoben, Leoben, , Austria
LKH Steyr, Steyr, , Austria
Klinikum Wels-Grieskirchen GmbH, Wels, , Austria
AKH Universitätsklinik für Innere Medizin I, Wien, , Austria
Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Cité de la Santé de Laval, Laval, Quebec, Canada
CHUM Hôpital Notre-Dame, Montreal, Quebec, Canada
Mc Gill University Hospital, Montreal, Quebec, Canada
Hôpital Charles LeMoyne, Montreal, Quebec, Canada
Hôpital Maisonneuve-Rosemont, Montréal, Quebec, Canada
Centre Hospitalier, Antibes, , France
Centre Hospitalier, Auxerre, , France
Centre Hospitalier, Beauvais, , France
Hôpital Avicenne, Bobigny, , France
Polyclinique Bordeaux Nord, Bordeaux, , France
Centre Hospitalier, Briey, , France
Hôpital Pasteur, Colmar, , France
Centre Hospitalier, Dax, , France
Hopital Drevon, Dijon, , France
CHD les oudairies, La Roche sur Yon, , France
Clinique Victor Hugo, Le Mans, , France
Hopital Robert Boulin, Libourne, , France
CHU Dupuytren, Limoges, , France
Centre Hospitalier Saint Joseph Saint Luc, Lyon, , France
Hôpital Privé Jean Mermoz, Lyon, , France
Clinique de la sauvegarde, Lyon, , France
hôpital Ambroise Paré, Marseille, , France
Institu Paoli Calmette, Marseille, , France
Centre Hospitalier, Meaux, , France
Clinique Claude BERNARD, Metz, , France
Centre hospitalier Layné, Mont de Marsan, , France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil, Montfermeil, , France
centre oncologie de Gentilly, Nancy, , France
Centre Catherine de Sienne, Nantes, , France
Institut Curie, Paris, , France
Groupe Hospitalier les Diaconnesses, Paris, , France
Hôpital Pitié Salpêtrière, Paris, , France
Hôpital Saint Joseph, Paris, , France
Institut Mutualiste Montsouris, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Tenon, Paris, , France
centre Catalan oncologie, Perpignan, , France
Clinique Armoricaine, Saint Brieuc, , France
Centre Hospitalier, Semur en Auxois, , France
C.H. Senlis, Senlis, , France
Hopital Foch, Suresnes, , France
Clinique Générale, Valence, , France
Contact Details
Name: Aimery de Gramont, MD
Affiliation: Hopital Saint Antoine
Role: STUDY_CHAIR
Name: Christophe Tournigand, MD
Affiliation: Hopital Henri Mondor
Role: STUDY_CHAIR
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