Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | May 2006 |
Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma
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.
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.
DISEASE CHARACTERISTICS:
- Histologically confirmed* hepatocellular carcinoma
- Unresectable disease
- Child's class A or B with liver-predominant and asymptomatic extrahepatic
disease NOTE: *A highly suspicious liver mass on CT scan or MRI in the presence
of alpha fetoprotein > 200 mg/dL may be used as alternative diagnostic criterion
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 50,000/mm³
- AST and ALT < 5.0 times upper limit of normal (ULN)
- Bilirubin ≤ 5.0 mg/dL
- Creatinine normal OR creatinine clearance > 50 mL/min
- No significant traumatic injury within the past 28 days
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months
- No serious, nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
- No major surgery or open biopsy within the past 28 days
- No minor surgery (e.g., fine-needle aspirations or core biopsies) within the past 7
days
- No chemotherapy within the past 4 weeks
- No radiotherapy within the past 21 days
- No concurrent major surgery
- No other concurrent chemotherapy
- No other concurrent investigational drugs
We found this trial at
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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