Oxaliplatin, Capecitabine, and Cetuximab in Treating Patients With Advanced Liver Cancer
- Conditions
- Liver Cancer
- Interventions
- Registration Number
- NCT00483405
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Trial cetuximab Single Arm Trial Single Arm Trial oxaliplatin Single Arm Trial Single Arm Trial capecitabine Single Arm Trial
- Primary Outcome Measures
Name Time Method Disease Response Rate 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.
- Secondary Outcome Measures
Name Time Method Number of Subjects Experiencing Adverse Events every 3 weeks of treatment with an average of 15 weeks on treatment Adverse events will be assessed using CTCAE criteria.
Overall Survival Median 23 month follow-up Overall survival will be calculated from time of enrollment to death or last contact date.
Time to Progression 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.
Trial Locations
- Locations (1)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States