Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483405
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2007-06-06
Brief Title:
Oxaliplatin Capecitabine and Cetuximab in Treating Patients With Advanced Liver Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Oxaliplatin Capecitabine and Cetuximab in Advanced Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NRR
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K23CA118431-02 | NIH | None | httpsreporternihgovquickSearch5K23CA118431-02 |
| KL2RR025746 | NIH | None | None |