S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed colorectal carcinoma
• * Inoperable, locally advanced, or metastatic disease
• * KRAS-mutated
• Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer
• Measurable disease according to RECIST
• No moderate or severe ascites or pleural effusion requiring treatment
• No metastasis to the CNS
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-2
• White blood cell count \> 3,500/mm³ but \< 12,000/mm³
• Neutrophil count \> 1,500/mm³
• Hemoglobin \> 9.0 g/dL
• Platelet count \> 100,000/mm³
• Total bilirubin \< 1.5 mg/dL
• AST and ALT \< 100 U/L (\< 200 U/L in patients with liver metastasis)
• Serum creatinine \< 1.2 mg/dL
• Creatinine clearance ≥ 50 mL/min
• Urine dipstick for proteinuria \< 1+
• INR \< 1.5
• Not pregnant or nursing
• Able to take capsules orally
• No active second cancer
• No active infections (e.g., patients with pyrexia of ≥ 38°C)
• No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension)
• No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator
• No serious drug hypersensitivity or a history of drug allergy
• No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
• No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
• No clinically significant traumatic injury within the past 4 weeks
• No severe mental disorder
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Concurrent low-dose aspirin therapy (\< 325 mg/day) allowed
• More than 4 weeks since prior major surgical procedure or open biopsy
• No prior therapy radiotherapy
• No prior therapy with S-1
• No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment.
• No concurrent continuous treatment with steroids
• No concurrent treatment with flucytosine