Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma
- Determine the response rate in patients with advanced hepatocellular carcinoma and
hepatic dysfunction treated with oxaliplatin, capecitabine, and cetuximab.
- 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
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease Response Rate
Radiographic response will be measured every sis weeks while subject is on treamtment. Response will be measured using RECIST criteria.
every 6 weeks
Bert H. O'Neil, MD
UNC Lineberger Comprehensive Cancer Center
United States: Federal Government
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|