Liver Cancer Clinical Trial
Official title:
Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Monoclonal antibodies, such as cetuximab, 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. Giving chemotherapy
together with a monoclonal antibody may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine
together with cetuximab works in treating patients with advanced liver cancer.
OBJECTIVES:
Primary
- Determine the response rate in patients with advanced hepatocellular carcinoma and
hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.
Secondary
- Determine the safety of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
- Determine the time to tumor progression in patients treated with this regimen.
OUTLINE: This is an open label, nonrandomized study.
Patients receive oral capecitabine twice daily on days 1-14, cetuximab IV over 60-120
minutes on days 1, 8, and 15, and oxaliplatin IV over 120 minutes on day 1. Treatment
repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 3-4 weeks and then every 3
months thereafter.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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