Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055692
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2003-03-06
Brief Title:
Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Bevacizumab RhuMAB-VEGF In Hepatocellular Cancer For Patients With Unresectable Tumor Without Invasion Of The Main Portal Vein Or Metastatic Disease A Phase II Study
Status:
COMPLETED
Status Verified Date:
2012-12
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 to see if bevacizumab works in treating patients who have unresectable nonmetastatic liver cancer that has not spread to the main portal vein Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them
Detailed Description:
OBJECTIVES
I Determine the efficacy of bevacizumab in terms of progression-free survival and disease stability and response in patients with unresectable nonmetastatic hepatocellular cancer HCC without main portal vein invasion
II Determine the safety of this drug in these patients III Assess tumor vascular perfusion kinetics by dynamic gadolinium-enhanced MRI in patients before and after treatment with this regimen
IV Determine the effect of vascular endothelial growth factor VEGF-inhibition by this drug on circulating levels of VEGF and related cytokines that also contribute to HCC pathogenesis including bFGF TGF-alpha and IGF-II and on potential alterations of these levels on prognostic variables in these patients
V Determine the effect of VEGF-inhibition by this drug on hepatic function and hepatitis viral activity in cirrhosis in these patients
OUTLINE This is a multicenter pilot study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-46 patients will be accrued for this study
I Determine the efficacy of bevacizumab in terms of progression-free survival and disease stability and response in patients with unresectable nonmetastatic hepatocellular cancer HCC without main portal vein invasion
II Determine the safety of this drug in these patients III Assess tumor vascular perfusion kinetics by dynamic gadolinium-enhanced MRI in patients before and after treatment with this regimen
IV Determine the effect of vascular endothelial growth factor VEGF-inhibition by this drug on circulating levels of VEGF and related cytokines that also contribute to HCC pathogenesis including bFGF TGF-alpha and IGF-II and on potential alterations of these levels on prognostic variables in these patients
V Determine the effect of VEGF-inhibition by this drug on hepatic function and hepatitis viral activity in cirrhosis in these patients
OUTLINE This is a multicenter pilot study
Patients receive bevacizumab IV over 30-90 minutes on day 1 Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-46 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 |
|---|---|---|---|
| N01CM62203 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62203 |
| NCI-2012-02518 | OTHER | None | None |
| NCI-5611 | OTHER | None | None |
| 5611 | OTHER | None | None |
| P30CA013330 | NIH | None | None |
| N01CM62204 | NIH | None | None |