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