A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous
hepatic biopsy

- Resectable hepatic metastases by any of the following:

- Minor resection (i.e., less than a hemihepatectomy)

- Major resection (i.e., hemihepatectomy or extended hepatectomy)

- Bilobar resection (including atypical resection)

- Synchronous primary tumor and hepatic metastases allowed

- Radiologic evidence of hepatic metastases by multiphasic contrast-enhanced spiral CT
scan

- Resectable primary colorectal cancer that is in place allowed

- Measurable disease

- No evidence of extrahepatic metastases by chest x-ray or CT scan of the chest

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin ≥ 9.0 g/dL

- WBC ≥ 3,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2.5 times ULN

Renal

- Creatinine clearance ≥ 60 mL/min

- Urine protein/creatinine ratio < 1 OR

- Urine protein < 1 g by 24-hour urine collection

Cardiovascular

- No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg)

- History of hypertension allowed provided it is well controlled on a stable
regimen of anti-hypertensive therapy

- No arterial thromboembolic event within the past 12 months, including any of the
following:

- Transient ischemic attack

- Cerebrovascular accident

- Unstable angina

- Myocardial infarction

- No peripheral vascular disease ≥ grade 2

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No pre-existing peripheral neuropathy ≥ grade 2

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 6 months since prior adjuvant chemotherapy for the primary tumor

- No prior systemic chemotherapy for metastatic disease

- No prior hepatic artery infusion chemotherapy for metastatic disease

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for metastatic disease

Surgery

- More than 7 days since prior colonoscopy or fine needle aspiration

- More than 28 days since prior major invasive surgery or open biopsy

Other

- At least 4 weeks since prior and no concurrent sorivudine or brivudine

- No prior radiofrequency ablation for metastatic disease

- No prior cryotherapy for metastatic disease

- No other prior ablative techniques for metastatic disease

- No concurrent cimetidine

- Concurrent ranitidine or other drug from a different antiulcer class allowed

- No concurrent oral anticoagulation for treatment of thrombosis

- Concurrent warfarin (1 mg) to maintain patency of central venous catheter
allowed