Status:
WITHDRAWN
S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Mo...
Detailed Description
OBJECTIVES: * Determine the proportion of patients with resectable hepatic metastases secondary to colorectal cancer who undergo surgical resection and achieve a R0 resection after treatment with neo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00118105
Start Date
November 1 2006
End Date
April 1 2007
Last Update
January 3 2013
Active Locations (46)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
2
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
3
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
4
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801