S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer

• Status: Withdrawn
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI)
• Treatments: Bevacizumab; Capecitabine; Oxaliplatin

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