S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, recurrent rectal cancer, stage IV rectal cancer, liver metastases
Eligibility 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
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital
- Rush-Copley Cancer Care Center
- Joliet Oncology-Hematology Associates, Limited - West
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Research Center at Boston Medical Center
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Community Hospital
- Frontier Cancer Center
- Great Falls Clinic
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Wayne Memorial Hospital, Incorporated
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Charles F. Kettering Memorial Hospital
- St. Rita's Medical Center
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Danville Regional Medical Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Chemotherapy + Surgery + Chemotherapy
Preoperative Neoadjuvant Chemotherapy Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4 Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 Oxaliplatin, 130 mg/m^2, IV, Day 1 of cycles 1,2,3,4 Capecitabine, 1,700 mg/m^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4