Status:
COMPLETED
Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
The first step in this study is to examine the tumor biopsy (previously collected) and determine whether or not it is epidermal growth factor receptor (EGFR) positive or EGFR negative. Both EGFR posit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00142428
Start Date
January 1 2005
End Date
October 1 2008
Last Update
March 18 2014
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115