Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077441
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-02-10
Brief Title:
Bortezomib in Treating Patients With Hepatocellular Carcinoma Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma
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:
This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma liver cancer that cannot be removed with surgery Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Proportion of confirmed tumor responses
SECONDARY OBJECTIVES
I To evaluate the confirmed and objective response rate II To assess patient outcome as estimated by duration of response time to disease progression and survival
III To evaluate the adverse event rates associated with PS-341 in this population
IV To explore the relationships between laboratory correlates eg IHC and patient outcome eg p53 and disease progression
V To evaluate alterations in laboratory correlates from pre-treatment measurements ie pre and post treatment The following immunohistochemistry IHC assays will be performed IHC of p53 IHC of p21 IHC of p27 IHC of NFkB IHC of Ki67
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry
I Proportion of confirmed tumor responses
SECONDARY OBJECTIVES
I To evaluate the confirmed and objective response rate II To assess patient outcome as estimated by duration of response time to disease progression and survival
III To evaluate the adverse event rates associated with PS-341 in this population
IV To explore the relationships between laboratory correlates eg IHC and patient outcome eg p53 and disease progression
V To evaluate alterations in laboratory correlates from pre-treatment measurements ie pre and post treatment The following immunohistochemistry IHC assays will be performed IHC of p53 IHC of p21 IHC of p27 IHC of NFkB IHC of Ki67
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry
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 |
|---|---|---|---|
| N01CM62205 | NIH | None | httpsreporternihgovquickSearchN01CM62205 |
| MC0255 | None | None | None |