Status and phase
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Study type
Funder types
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About
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.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study.
NOTE: *Bevacizumab is administered during courses 1-3 of neoadjuvant therapy.
NOTE: **Bevacizumab is administered during courses 1-4 of adjuvant therapy.
After completion of study treatment, patients are followed every 4 months until disease progression and then every 6 months for up to 3 years from study entry.
PROJECTED ACCRUAL: Approximately 35-65 patients will be accrued for this study.
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of hepatic metastases secondary to colorectal cancer by percutaneous hepatic biopsy
Resectable hepatic metastases by any of the following:
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No uncontrolled hypertension (i.e., blood pressure > 150/90 mm Hg)
No arterial thromboembolic event within the past 12 months, including any of the following:
No peripheral vascular disease ≥ grade 2
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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
No concurrent oral anticoagulation for treatment of thrombosis
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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