NCT00483405

Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer

Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	250 mg/m2, intravenously, once per week
DRUG	capecitabine	850 mg/m2, orally, twice daily (dose rounded to accommodate 150 mg and 500 mg tablet sizes. Capecitabine given on days 1-14 of 21 day cycle.
DRUG	oxaliplatin	130 mg/m2, intravenously on Day 1 of each 21 day cycle

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-02-01
• Completion: 2010-12-01
• First posted: 2007-06-07
• Last updated: 2017-07-12
• Results posted: 2017-05-09

Locations

1 site across 1 country: United States