Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer (NRR)
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.
|Liver Cancer||Biological: cetuximab Drug: capecitabine Drug: oxaliplatin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Study of Oxaliplatin, Capecitabine, and Cetuximab in Advanced Hepatocellular Carcinoma|
- Disease Response Rate [ Time Frame: 42 days (2 cycles) ]
Radiographic response will be measured every six weeks while subject is on treatment. Response will be measured using RECIST criteria.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
- Number of Subjects Experiencing Adverse Events [ Time Frame: every 3 weeks of treatment with an average of 15 weeks on treatment ]Adverse events will be assessed using CTCAE criteria.
- Overall Survival [ Time Frame: Median 23 month follow-up ]Overall survival will be calculated from time of enrollment to death or last contact date.
- Time to Progression [ Time Frame: Median 23 month follow-up ]Time to progression will be calculated from the time of enrollment until confirmed disease progression. Defined by RECIST (Response Evaluation Criteria in Solid Tumors), Progressive Disease (PD) - at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
|Study Start Date:||October 2006|
|Study Completion Date:||December 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Single Arm Trial
Single Arm Trial
250 mg/m2, intravenously, once per week
Other Name: ErbituxDrug: 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.
Other Name: XelodaDrug: oxaliplatin
130 mg/m2, intravenously on Day 1 of each 21 day cycle
Other Name: Eloxatin
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483405
|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|