Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Yale University

Status and phase

Completed

Phase 2

Conditions

Liver Cancer

Treatments

Drug: embolization therapy

Biological: bevacizumab

Procedure: hepatic artery infusion

Drug: chemotherapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00335829

JHOC-J0598

J0598 CDR0000483104

JHOC-NA_00001249

Details and patient eligibility

About

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.

Full description

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.

Enrollment

26 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count > 1,500/mm³
Platelet count > 50,000/mm³
Aspartate aminotransferase (AST) and alanine aminotransferase (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