Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365391
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2006-08-16
Brief Title:
Bevacizumab and Erlotinib in Treating Patients With Advanced Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Bevacizumab Plus Erlotinib in Patients With Advanced Hepatocellular Cancer HCC
Status:
COMPLETED
Status Verified Date:
2013-03
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 giving bevacizumab together with erlotinib works in treating patients with advanced liver cancer Monoclonal antibodies such as bevacizumab 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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood flow to the tumor Giving bevacizumab together with erlotinib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the objective response rate in patients with advanced hepatocellular carcinoma treated with bevacizumab and erlotinib
SECONDARY OBJECTIVES
I Evaluate the time to progression in patients treated with this regimen II Evaluate the overall and progression-free survival of patients treated with this regimen
III Evaluate the adverse events in patients treated with this regimen
TERTIARY OBJECTIVES
I Determine the presence of epidermal growth factor receptor EGFR mutations in tumor tissue and correlate this with response rate progression and survival in patients treated with this regimen
II Evaluate the expression of molecules involved in EGFR signal transduction including EGFR phosphorylated-EGFR Akt phosphorylated-Akt mitogen-activated protein kinase MAPK phosphorylated-MAPK and HER2neu by immunohistochemistry from tumor tissue and correlate these with patient outcome measures
III Determine the levels of vascular endothelial growth factor VEGF and VEGF receptors in tumor tissue as well as baseline plasma VEGF levels and correlate these with patient outcome measures
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo laboratory studies to determine epidermal growth factor receptor EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immunohistochemistry IHC for correlation with clinical outcome Levels of proteins through which EGFR signals including Akt phosphorylated-Akt mitogen-activated protein kinase MAPK and phosphorylated-MAPK are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by enzyme-linked immunosorbent assays ELISA
After completion of study treatment patients are followed periodically for up to 3 years
I Evaluate the objective response rate in patients with advanced hepatocellular carcinoma treated with bevacizumab and erlotinib
SECONDARY OBJECTIVES
I Evaluate the time to progression in patients treated with this regimen II Evaluate the overall and progression-free survival of patients treated with this regimen
III Evaluate the adverse events in patients treated with this regimen
TERTIARY OBJECTIVES
I Determine the presence of epidermal growth factor receptor EGFR mutations in tumor tissue and correlate this with response rate progression and survival in patients treated with this regimen
II Evaluate the expression of molecules involved in EGFR signal transduction including EGFR phosphorylated-EGFR Akt phosphorylated-Akt mitogen-activated protein kinase MAPK phosphorylated-MAPK and HER2neu by immunohistochemistry from tumor tissue and correlate these with patient outcome measures
III Determine the levels of vascular endothelial growth factor VEGF and VEGF receptors in tumor tissue as well as baseline plasma VEGF levels and correlate these with patient outcome measures
OUTLINE This is a multicenter study
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients undergo laboratory studies to determine epidermal growth factor receptor EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immunohistochemistry IHC for correlation with clinical outcome Levels of proteins through which EGFR signals including Akt phosphorylated-Akt mitogen-activated protein kinase MAPK and phosphorylated-MAPK are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by enzyme-linked immunosorbent assays ELISA
After completion of study treatment patients are followed periodically for up to 3 years
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 |
|---|---|---|---|
| MC044I | None | None | None |
| N01CM62205 | NIH | None | httpsreporternihgovquickSearchN01CM62205 |