Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187486
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2005-09-13
Brief Title:
Safety and Efficacy Study of Tarceva Temodar and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Phase II Study of Tarceva Plus Temodar During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme and Gliosarcoma
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy This is called a phase II study The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma All patients will receive radiation and Temodar plus Tarceva There is no placebo drug
Detailed Description:
This is a Phase II Study of Tarceva plus Temodar during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma The efficacy and safety profile of Tarceva in combination with radiation therapy plus Temodar will be studied In addition correlations between response to treatment and epidermal growth factor receptor EGFR status as well as other molecular markers of tumor prior to treatment will be explored Patients will be stratified according to enzyme inducing anti epileptic drug EIAED use Group A not on EIAEDs will take 100 milligrams mg Tarcevaday during radiotherapy and start with a dose of 150 mg Tarcevaday two weeks after radiotherapy Group B on EIAEDs will take 200mg Tarcevaday during radiotherapy and start with a dose of 300 mg Tarcevaday two weeks after radiotherapy Both groups will take 75 mgm2 Temodarday during radiotherapy and 200 mgm2 Temodarday x 5 two weeks after radiotherapy Intrapatient Tarceva dose escalation may occur every two weeks after radiotherapy until the appearance of a particular rash severity The maximum dose allowed is 200 mg for group A and 500 mg for group B
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 |
|---|---|---|---|
| OSI 2725s | OTHER | Genentech Inc | None |