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 adenocarcinoma of the colon or rectum
• * No other histological types
• Metastatic, unresectable disease
• * No bone metastases only
• Unidimensionally measurable metastatic disease
• No CNS metastases
• PATIENT CHARACTERISTICS:
• WHO performance status (PS) 0-2 OR Karnofsky PS 70-100%
• Life expectancy ≥ 12 weeks
• ANC \> 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Bilirubin ≤ 1.25 times normal (1.5 times normal in presence of hepatic metastases)
• AST and ALT \< 3 times normal (5 times normal in presence of hepatic metastases)
• Creatinine \< 1.25 times normal
• No proteinuria
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other cancer in the past 5 years except for carcinoma in situ of the uterine cervix or basal cell skin cancer
• No hypersensitivity to fluorouracil
• No hypersensitivity to leucovorin calcium, bevacizumab, or their excipients
• No hypersensitivity to Chinese hamster ovarian cell products or other recombinant humanized or nonhumanized monoclonal antibodies
• No allergy to irinotecan hydrochloride
• No prior reaction to attenuated vaccines (fever, jaundice)
• No poor nutritional status
• No Biermer anemia or other anemia due to vitamin B12 deficiency
• No uncontrolled symptomatic occlusion or subocclusion
• No medullary hypoplasia or severe insufficiency
• No prior chronic intestinal disease
• No Gilbert's syndrome
• No intra-abdominal inflammatory reaction (e.g., gastroduodenal ulcer, diverticulitis, or colitis)
• No chronic intestinal inflammatory disease
• No thromboembolic arterial condition in the past 6 months, including any of the following:
• * Cardiovascular accident
• * Transient ischemic attack
• * Myocardial infarction
• No infection or serious noncancerous disease
• No condition that is unstable or would increase risk to the patient, including any of the following:
• * Unstable angina
• * Poorly controlled hypertension
• * Severe cardiac insufficiency
• * Serious arrhythmia
• * Bleeding diathesis
• * Pulmonary disease at risk of decompensation
• No familial, geographical, social, or psychological condition that would preclude study participation
• No prisoners or patients without guardians
• PRIOR CONCURRENT THERAPY:
• At least 8 weeks since prior surgery
• At least 6 months since prior adjuvant chemotherapy
• At least 1 month since prior palliative chemotherapy
• No prior abdominal or pelvic radiotherapy
• At least 30 days since prior participation in another investigational study
• No prior bevacizumab
• No extensive intestinal resection (e.g., partial colectomy or extensive thin resection)
• No concurrent warfarin, Hypericum perforatum (St. John's wort), or prophylactic phenytoin