Bevacizumab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed colorectal cancer
• * Unresectable metastatic disease
• Measurable disease
• No CNS metastases
• PATIENT CHARACTERISTICS:
• WHO performance status 0-2
• Life expectancy \> 3 months
• Absolute neutrophil count \> 1,500/mm³
• Platelet count \> 100,000/mm³
• Hemoglobin \> 9 g/dL (transfusion allowed)
• INR \< 1.5
• Alkaline phosphatase \< 1.5 times upper limit of normal (ULN)
• Bilirubin \< 1.5 times ULN
• AST and ALT \< 2.5 times ULN (5 times ULN if liver metastases are present)
• Creatinine clearance \> 30 mL/min
• Urine protein \< 2+ OR ≤ 1 g/L by 24-hour urine collection
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No contraindications to study therapy
• No gastrointestinal or duodenal ulcers
• No AIDS
• No serious illness, active infection, or other serious condition that would preclude study therapy
• No coagulation problem
• No bleeding diathesis
• No sensitivity to Chinese hamster ovarian cells or other recombinant human antibodies
• No severe renal insufficiency
• No uncontrolled hypertension
• No active or severe cardiovascular conditions, including the following:
• * Cerebrovascular accident
• * Myocardial infarction within the past 6 months
• * New York Heart Association class II-IV cardiac insufficiency
• * Severe cardiac arrhythmia (even if treated)
• No primitive stenosis or symptomatic peritoneal carcinosis causing a risk of intestinal subocclusion or occlusion
• No nonhealing wound or fracture
• No prior thromboembolic disease
• No other cancer within the past 2 years except for basal cell skin cancer or carcinoma in situ of the uterine cervix
• No geographical, social, or psychological condition that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• No prior chemotherapy for metastatic disease
• At least 6 months since prior adjuvant chemotherapy (fluorouracil with or without oxaliplatin)
• * No prior adjuvant chemotherapy comprising irinotecan hydrochloride with or without bevacizumab
• At least 28 days since prior major surgery
• Prior radiotherapy allowed except to target lesions
• At least 10 days since prior anticoagulants
• No concurrent chronic acetylsalicylic acid (at doses \> 325 mg/day)
• No other concurrent investigational therapy
• No other concurrent anticancer therapy