Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301418
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2006-03-09
Brief Title:
Oral Tarceva Study for RecurrentResidual Glioblastoma Multiforme and Anaplastic Astrocytoma
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Phase III Trial of Oral Erlotinib Tarceva OSI-774 for Treatment of RelapsedRefractory Glioblastoma Multiforme and Anaplastic Astrocytoma
Status:
COMPLETED
Status Verified Date:
2016-01
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 study will offer a safe treatment for patients with relapsing recurring glioblastoma GBM or anaplastic astrocytoma AA The trial will test the hypothesis that Erlotinib Tarceva OSI-774 can be safely used up to a dose of 150 mg two times a day for 12 months to ultimately enhance survival of patients with relapsedrefractory GBMAA Correlation of response to Tarceva with particular genetic alterations including epidermal growth factor receptor variant type III EGFRvIII amplification and phosphatase and tensin homolog mutated in multiple advanced cancers 1 PTEN loss will be studied
Detailed Description:
The high-grade malignant brain tumors glioblastoma multiforme GBM and anaplastic astrocytoma AA comprise the majority of all primary brain tumors in adults This group of tumors also exhibits the most aggressive behavior resulting in median overall survival durations of only 9-12 months for GBM and 3-4 years for AA from initial diagnosis despite multimodal treatment approaches Initial therapy consists of either surgical resection external beam radiation or both The role of adjuvant or concomitant chemotherapy in the initial therapy of GBM and AA has not as yet been clearly defined Since most of these patients experience a recurrence after first-line therapy improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival In August 2003 the US Food and Drug Administration FDA granted orphan drug status for Erlotinib in patients with malignant glioma Erlotinib OSI-774 has been shown to be active in a range of tumors including GBM AA and non small cell lung cancer Because of the promising results in preliminary studies of Erlotinib and because of significant experience with the safety of the dosages proposed in this study this study will offer a safe adjuvant treatment for patients with relapsing recurring glioblastoma or anaplastic astrocytoma Therefore this phase III clinical research trial will test the hypothesis that Erlotinib can be safely used up to a dose of 150 mg bid for 12 cycles to ultimately enhance survival of patients with relapsedrefractory GBMAA with particular genetic alterations including EGFRvIII amplification and PTEN loss
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