Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052364
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2003-01-24
Brief Title:
Oxaliplatin in Treating Patients With Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Hepatocellular Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
Phase II trial to study the effectiveness of oxaliplatin in treating patients who have unresectable recurrent or metastatic liver cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To assess response rate and progression free survival in patients with hepatocellular cancer treated with oxaliplatin
II To assess the toxicity and tolerance of oxaliplatin in patient with hepatocellular cancer
III To evaluate the mRNA expression of enzymes in tumors of the patients entered on this study which may be important to the cytotoxicity of oxaliplatin ERCC1 mismatch repair ribonucleotide reductase bcl-2 bax p53 An attempt will be made to obtain tumor biopsies from all patients
OUTLINE This is a multicenter study Patients are stratified according to presence of the fibrolamellar variant of hepatocellular cancer yes vs no
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study
I To assess response rate and progression free survival in patients with hepatocellular cancer treated with oxaliplatin
II To assess the toxicity and tolerance of oxaliplatin in patient with hepatocellular cancer
III To evaluate the mRNA expression of enzymes in tumors of the patients entered on this study which may be important to the cytotoxicity of oxaliplatin ERCC1 mismatch repair ribonucleotide reductase bcl-2 bax p53 An attempt will be made to obtain tumor biopsies from all patients
OUTLINE This is a multicenter study Patients are stratified according to presence of the fibrolamellar variant of hepatocellular cancer yes vs no
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 18-32 patients will be accrued for this study
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 |
|---|---|---|---|
| N01CM17101 | NIH | None | httpsreporternihgovquickSearchN01CM17101 |
| PHII-36 | None | None | None |