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)

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.

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.