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)
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00265824
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description bevacizumab alone bevacizumab - Bevacizumab + erlotinib bevacizumab, erlotinib -
- Primary Outcome Measures
Name Time Method Progression-free survival during maintenance therapy Tumor evaluation every 2 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Institut Curie
🇫🇷Paris, France
Hôpital Saint Joseph
🇫🇷Paris, France
Hopital Saint Antoine
🇫🇷Paris, France
Klinikum Wels-Grieskirchen GmbH
🇦🇹Wels, Austria
LKH Steyr
🇦🇹Steyr, Austria
AKH Universitätsklinik für Innere Medizin I
🇦🇹Wien, Austria
Cité de la Santé de Laval
🇨🇦Laval, Quebec, Canada
Mc Gill University Hospital
🇨🇦Montreal, Quebec, Canada
C.H. Senlis
🇫🇷Senlis, France
Centre hospitalier Layné
🇫🇷Mont de Marsan, France
Hopital Robert Boulin
🇫🇷Libourne, France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
🇫🇷Montfermeil, France
centre oncologie de Gentilly
🇫🇷Nancy, France
Clinique de la sauvegarde
🇫🇷Lyon, France
CHD les oudairies
🇫🇷La Roche sur Yon, France
Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier
🇫🇷Semur en Auxois, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Hôpital Pasteur
🇫🇷Colmar, France
Centre Hospitalier Saint Joseph Saint Luc
🇫🇷Lyon, France
Institu Paoli Calmette
🇫🇷Marseille, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
Hôpital Pitié Salpêtrière
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Clinique Claude BERNARD
🇫🇷Metz, France
centre Catalan oncologie
🇫🇷Perpignan, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Clinique Armoricaine
🇫🇷Saint Brieuc, France
Ottawa Hospital Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
CHUM Hôpital Notre-Dame
🇨🇦Montreal, Quebec, Canada
LKH Leoben
🇦🇹Leoben, Austria
Hôpital Charles LeMoyne
🇨🇦Montreal, Quebec, Canada
Polyclinique Bordeaux Nord
🇫🇷Bordeaux, France
CHU Dupuytren
🇫🇷Limoges, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Groupe Hospitalier les Diaconnesses
🇫🇷Paris, France
Clinique Générale
🇫🇷Valence, France
hôpital Ambroise Paré
🇫🇷Marseille, France
Hopital Drevon
🇫🇷Dijon, France
Hopital Foch
🇫🇷Suresnes, France