Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically\* or cytologically\* confirmed colorectal cancer
• * Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery
• * Metastatic disease NOTE: \*Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of \> 5 years has elapsed between initial primary surgery and the development of metastases
• Measurable disease
• * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No known curative therapy exists
• No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases)
• PATIENT CHARACTERISTICS:
• Age
• 70 and over
• Performance status
• ECOG 0-1
• Life expectancy
• More than 3 months
• Hematopoietic
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• No bleeding diathesis or coagulopathy
• Hepatic
• Bilirubin normal
• AST and ALT ≤ 3 times upper limit of normal (ULN)
• INR \< 1.5 (unless on therapeutic anticoagulants)
• No unstable or uncompensated hepatic disease
• Renal
• Creatinine \< 1.2 times ULN OR
• Creatinine clearance \> 60 mL/min
• No unstable or uncompensated renal disease
• Cardiovascular
• No history of stroke
• No uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg on medication)
• No myocardial infarction within the past year
• No New York Heart Association class II-IV congestive heart failure
• No unstable angina
• No serious cardiac dysrhythmia requiring medication
• No other clinically significant cardiovascular disease
• No other unstable or uncompensated cardiac disease
• Pulmonary
• No unstable or uncompensated respiratory disease
• Other
• Fertile patients must use effective contraception
• Able to receive oral medication
• No known hypersensitivity to fluorouracil or capecitabine
• No known dihydropyrimidine dehydrogenase deficiency
• No seizures not controlled by standard medical therapy
• No serious nonhealing wound, ulcer, or bone fracture
• No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix
• No other severe or uncontrolled systemic disease
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No prior bevacizumab
• Chemotherapy
• Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered \> 6 months before the development of metastatic disease
• No prior chemotherapy for metastatic colon cancer
• No prior irinotecan or oxaliplatin
• Endocrine therapy
• Not specified
• Radiotherapy
• Not specified
• Surgery
• See Disease Characteristics
• More than 28 days since prior and no concurrent major surgery
• More than 28 days since prior open biopsy
• More than 7 days since prior fine needle aspiration or core biopsy
• Other
• More than 4 weeks since prior and no concurrent participation in another experimental drug study
• More than 30 days since prior non-approved or investigational drugs