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
馃嚝馃嚪Paris, France
H么pital Saint Joseph
馃嚝馃嚪Paris, France
Hopital Saint Antoine
馃嚝馃嚪Paris, France
Klinikum Wels-Grieskirchen GmbH
馃嚘馃嚬Wels, Austria
LKH Steyr
馃嚘馃嚬Steyr, Austria
AKH Universit盲tsklinik f眉r Innere Medizin I
馃嚘馃嚬Wien, Austria
Cit茅 de la Sant茅 de Laval
馃嚚馃嚘Laval, Quebec, Canada
Mc Gill University Hospital
馃嚚馃嚘Montreal, Quebec, Canada
C.H. Senlis
馃嚝馃嚪Senlis, France
Centre hospitalier Layn茅
馃嚝馃嚪Mont de Marsan, France
Hopital Robert Boulin
馃嚝馃嚪Libourne, France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
馃嚝馃嚪Montfermeil, France
centre oncologie de Gentilly
馃嚝馃嚪Nancy, France
Clinique de la sauvegarde
馃嚝馃嚪Lyon, France
CHD les oudairies
馃嚝馃嚪La Roche sur Yon, France
H么pital Avicenne
馃嚝馃嚪Bobigny, France
H么pital Maisonneuve-Rosemont
馃嚚馃嚘Montr茅al, Quebec, Canada
Centre Hospitalier
馃嚝馃嚪Semur en Auxois, France
Clinique Victor Hugo
馃嚝馃嚪Le Mans, France
H么pital Pasteur
馃嚝馃嚪Colmar, France
Centre Hospitalier Saint Joseph Saint Luc
馃嚝馃嚪Lyon, France
Institu Paoli Calmette
馃嚝馃嚪Marseille, France
H么pital Priv茅 Jean Mermoz
馃嚝馃嚪Lyon, France
H么pital Piti茅 Salp锚tri猫re
馃嚝馃嚪Paris, France
Hopital Tenon
馃嚝馃嚪Paris, France
Clinique Claude BERNARD
馃嚝馃嚪Metz, France
centre Catalan oncologie
馃嚝馃嚪Perpignan, France
Institut Mutualiste Montsouris
馃嚝馃嚪Paris, France
Clinique Armoricaine
馃嚝馃嚪Saint Brieuc, France
Ottawa Hospital Regional Cancer Centre
馃嚚馃嚘Ottawa, Ontario, Canada
CHUM H么pital Notre-Dame
馃嚚馃嚘Montreal, Quebec, Canada
LKH Leoben
馃嚘馃嚬Leoben, Austria
H么pital Charles LeMoyne
馃嚚馃嚘Montreal, Quebec, Canada
Polyclinique Bordeaux Nord
馃嚝馃嚪Bordeaux, France
CHU Dupuytren
馃嚝馃嚪Limoges, France
Centre Catherine de Sienne
馃嚝馃嚪Nantes, France
Groupe Hospitalier les Diaconnesses
馃嚝馃嚪Paris, France
Clinique G茅n茅rale
馃嚝馃嚪Valence, France
h么pital Ambroise Par茅
馃嚝馃嚪Marseille, France
Hopital Drevon
馃嚝馃嚪Dijon, France
Hopital Foch
馃嚝馃嚪Suresnes, France