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Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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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 HopkinsBaltimore, Maryland  21231-2410