Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma|
- Disease Response Rate [ Time Frame: every 6 weeks ] [ Designated as safety issue: No ]Radiographic response will be measured every sis weeks while subject is on treamtment. Response will be measured using RECIST criteria.
- Number of subjects experiencing adverse events [ Time Frame: every 3 weeks of treatment ] [ Designated as safety issue: Yes ]Adverse events will be assessed using CTCAE critera.
- Overall Survival [ Time Frame: time of enrollment until death ] [ Designated as safety issue: No ]Overall survival will be calculated from time of enrollment to death or last contact date.
- Time to progression [ Time Frame: Enrollment until confirmed disease progression ] [ Designated as safety issue: No ]Time to progression will be calculated from the time of enrollment until confirmed disease progression
|Study Start Date:||October 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- 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 months thereafter.
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Principal Investigator:||Bert H. O'Neil, MD||UNC Lineberger Comprehensive Cancer Center|
|Principal Investigator:||Michael A. Morse, MD||Duke University|