Cetuximab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma
Completed · Phase 2
Conditions studied: Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT00142428
- Run by
- Massachusetts General Hospital
- People needed
- 30
- Starts
- 2005-01-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2014-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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