A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Inclusion Criteria

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