Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma
18 Years
N/A
Both
Liver Cancer
Trial Information
Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median progression-free survival
Outcome Time Frame:
Time to progression of the targeted lesion
Safety Issue:
No
Principal Investigator
Jeffrey F. Geschwind, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
J0598 CDR0000483104
NCT ID:
NCT00335829
Start Date:
May 2006
Completion Date:
February 2011
Related Keywords:
- Liver Cancer
- localized unresectable adult primary liver cancer
- adult primary hepatocellular carcinoma
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
