Second-Line Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer Who Have Received First-Line Chemotherapy and Bevacizumab

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed colorectal adenocarcinoma
• * Metastatic or unresectable disease
• Progressive disease based on the following criteria:
• * Progression during or after first-line chemotherapy for metastatic disease, including any of the following:
• * Fluoropyrimidine-based monotherapy with bevacizumab
• * Fluoropyrimidine and irinotecan hydrochloride-based doublet with bevacizumab
• * Fluoropyrimidine and oxaliplatin-based doublet with bevacizumab
• * Progression after more than 3 months from the last administration of first-line chemotherapy for metastatic disease with a fluoropyrimidine, irinotecan hydrochloride, and oxaliplatin triplet (FOLFOXIRI) with bevacizumab to which the patient had previously responded
• Measurable disease, as assessed by RECIST criteria
• No prior or concurrent CNS metastasis
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• Life expectancy \> 3 months
• ANC ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• INR ≤ 1.5 times upper limit of normal (ULN)
• aPTT ≤ 1.5 ULN
• Serum bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN (\< 5 times ULN if liver metastases present)
• Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN if liver metastases present)
• Serum creatinine ≤ 1.5 times ULN
• Proteinuria \< 2+ OR protein ≤ 1g by 24-hour urine
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No bowel obstruction or subobstruction
• No history of inflammatory enteropathy
• No prior extensive intestinal resection (i.e., \> hemicolectomy or extensive small intestine resection with chronic diarrhea)
• No symptomatic peripheral neuropathy \> grade 2
• No active uncontrolled infection
• No active disseminated intravascular coagulation
• No prior or concurrent malignancy, except for curatively treated basal cell and squamous cell carcinoma of the skin, or in situ carcinoma of the cervix
• No clinically significant cardiovascular disease, including any of the following:
• * Cerebrovascular accident within the past 6 months
• * Myocardial infarction within the past 6 months
• * Unstable angina
• * NYHA class II-IV chronic heart failure
• * Uncontrolled arrhythmia
• No uncontrolled hypertension
• No thromboembolic or hemorrhagic events within the past 6 months
• No evidence of bleeding diathesis or coagulopathy
• No serious, non healing wound/ulcer or serious bone fracture
• No significant traumatic injury within the past 28 days
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• At least 6 weeks since prior radiotherapy
• At least 4 weeks since prior surgery
• No prior first-line chemotherapy for metastatic disease without bevacizumab
• No prior cetuximab or other investigational agents
• More than 28 days since prior open biopsy
• More than 28 days since prior and no concurrent major surgical procedure
• No concurrent therapeutic anticoagulation, antiplatelet agents, or NSAID with anti-platelet activity
• * Acetylsalicylic acid ≤ 325 mg/day allowed