• Time to progression [ Designated as safety issue: No ]
  

• Response rate [ Designated as safety issue: No ]
  
• Median survival [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.

Secondary

• Determine the response rate in patients treated with this regimen.
• Determine the median survival of patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.

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 proteinuria OR clinically significant renal function impairment

  • Patients with ≥ 1+ proteinuria are eligible provided protein < 1,000 mg by 24-hour urine collection
• 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 peripheral vascular disease ≥ grade II
• 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 significant traumatic injury within the past 28 days
• 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