RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor. Giving bevacizumab together with chemoembolization may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery.
Primary Outcome Measures:
- Median progression-free survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Response rate [ Designated as safety issue: No ]
| Estimated Enrollment: |
30 |
| Study Start Date: |
May 2006 |
| Estimated Primary Completion Date: |
December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy.
Secondary
- Characterize the safety and toxicity of this regimen in these patients.
- Determine the response rate in patients treated with this regimen.
OUTLINE: Patients receive bevacizumab once in weeks 1, 3, and 5. Beginning in week 3, patients also receive transarterial chemoembolization (TACE) therapy. Treatment repeats approximately every 8 weeks for up to 3 courses. Patients achieving < 100% necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Purpose
