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

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