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)

Inclusion Criteria

• •MAIN ELIGIBILITY CRITERIA
• •Histologically proven metastatic adenocarcinoma of colon or rectum
• •Documented inoperable disease (i.e., not suitable for complete carcinological surgical resection)
• •Measurable lesion as assessed by CT scan or MRI in at least one dimension (longest diameter to be recorded) ≥ 20 mm with conventional CT scan or ≥ 10 mm with spiral CT scan
• •No previous therapy for metastatic disease
• •No history or evidence upon physical examination of CNS disease (e.g., non-irradiated CNS metastasis, seizure not controlled with standard medical therapy, or history of stroke) unless adequately treated
• •No exclusive bone metastasis
• •ECOG performance status 0-2
• •WBC ≥ 1,500/mm\^3
• •Platelets ≥ 100,000/mm\^3
• •Hemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level)
• •Proteinuria \< 2+ by dipstick OR ≤ 1 g of protein on 24-hr urine collection
• •Bilirubin \< 1.5 times ULN
• •Alkaline phosphatase \< 3 times ULN
• •No peripheral sensory neuropathy
• •Negative pregnancy test
• •Fertile patients must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly, or surgically sterilization)
• •No peripheral neuropathy ≥ grade 1
• •No clinically significant (i.e. active) cardiovascular disease
• •No evidence of bleeding diathesis or coagulopathy
• •No serious, non-healing wound, ulcer, or bone fracture
• •No significant ophthalmologic abnormality
• •More than 28 days since prior major surgical procedure or open biopsy