Combination Chemotherapy and Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
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.
Drug: bevacizumab, erlotinib
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Study of an Optimized Chemotherapy + Avastin Strategy ± Tarceva in Metastatic Colorectal Cancer|
- Progression-free survival during maintenance therapy [ Time Frame: Tumor evaluation every 2 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: bevacizumab alone||
bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity
|Experimental: Bevacizumab + erlotinib||
Drug: bevacizumab, erlotinib
bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
- Compare Progression-free survival during maintenance period ("Maintenance PFS")in patients with unresectable metastatic colorectal cancer.
- 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.
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
- 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.
|Institut Sainte Catherine|
|Avignon, France, 84000|
|Dijon, France, 21000|
|Clinique Victor Hugo|
|Le Mans, France, F-72000|
|Hopital Robert Boulin|
|Libourne, France, 33500|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Centre Hospitalier Intercommunal Le Raincy - Montfermeil|
|Montfermeil, France, 93370|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Senlis, France, 60309|
|Suresnes, France, 92151|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Study Chair:||Aimery de Gramont, MD||Hopital Saint Antoine|
|Study Chair:||Christophe Tournigand||Hopital Saint Antoine|