Phase III Study of an Optimized Chemotherapy + Avastin Strategy ± Tarceva in Metastatic Colorectal Cancer
- 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
- 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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival during maintenance therapy
Tumor evaluation every 2 months
Aimery de Gramont, MD
Hopital Saint Antoine
France : Agence Française de Sécurité Sanitaire et Produits de Santé (AFSSAPS)