Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to begin to collect information and to try to learn whether or not cetuximab works in treating patients with unresectable or metastatic hepatocellular carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Bristol-Myers Squibb; Dana-Farber Cancer Institute
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Unresectable or metastatic hepatocellular carcinoma

• Measurable tumor

• Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7 x upper limit of normal (ULN).

• Adequate renal function: serum creatinine < 2.0mg/dl

• Adequate bone marrow function: absolute neutrophil count (ANC) > 1,000/mm3; platelets > 75,000/mm3.

• 0-2 prior systemic chemotherapy regimens for hepatocellular carcinoma

• 18 years of age and older

• ECOG performance status of 0-2

• Life expectancy > 12 weeks

Exclusion Criteria:

• Surgery, excluding prior diagnostic biopsy or venous access device placement, within 28 days of study entry

• Uncontrolled serious medical or psychiatric illness

• Irradiation or chemotherapy for disease within 28 days of study entry

• Clinically apparent central nervous system metastases or carcinomatous meningitis

• Received an investigational agent within 30 days

• Cancer of the Liver Italian Program (CLIP) score > 3

• Acute hepatitis

• Active or uncontrolled infection

• Significant history of cardiac disease

• Prior cetuximab or other therapy which specifically and directly targets the EGFR pathway

• Prior allergic reaction to chimerized or murine monoclonal antibody therapy