Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445588
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2007-03-07
Brief Title:
Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Erlotinib OSI-774 and Sorafenib BAY 43-9006 for Patients With Progression or Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2016-03
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 erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Giving erlotinib together with sorafenib may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme
SECONDARY OBJECTIVES
I To assess and estimate the toxicities II Tumor response rate III To estimate 6-month progression free survival IV To describe the pharmacokinetics of this route of administration V For the Molecular Targeted Combinations Correlative MTC2 Study Initiative To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents
OUTLINE This is a multicenter open-label phase II study
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Tumor tissue and blood samples are collected prior to beginning treatment Samples are analyzed by immunohistochemistry gene expression and DNA mutation and genomic analyses of the epidermal growth factor receptor ras-raf-ERK and PI3K-Akt-mTOR pathways to identify markers that correlate with patient outcomes Blood samples are also collected on day 15 of course 1 for pharmacokinetic studies Samples are analyzed by reversed-phase isocratic high-performance liquid chromatography with electrospray ionization mass spectrometry to determine the concentration of erlotinib hydrochloride and sorafenib tosylate and its known metabolites
After completion of study therapy patients are followed every 2 months
I The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme
SECONDARY OBJECTIVES
I To assess and estimate the toxicities II Tumor response rate III To estimate 6-month progression free survival IV To describe the pharmacokinetics of this route of administration V For the Molecular Targeted Combinations Correlative MTC2 Study Initiative To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents
OUTLINE This is a multicenter open-label phase II study
Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Tumor tissue and blood samples are collected prior to beginning treatment Samples are analyzed by immunohistochemistry gene expression and DNA mutation and genomic analyses of the epidermal growth factor receptor ras-raf-ERK and PI3K-Akt-mTOR pathways to identify markers that correlate with patient outcomes Blood samples are also collected on day 15 of course 1 for pharmacokinetic studies Samples are analyzed by reversed-phase isocratic high-performance liquid chromatography with electrospray ionization mass spectrometry to determine the concentration of erlotinib hydrochloride and sorafenib tosylate and its known metabolites
After completion of study therapy patients are followed every 2 months
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 |
|---|---|---|---|
| U01CA062475 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062475 |
| NCI-2012-03018 | REGISTRY | None | None |
| CDR531731 | None | None | None |
| NABTT 0502 | OTHER | None | None |
| NABTT-0502 | OTHER | None | None |