Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00720356
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2008-07-19
Brief Title:
Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase II Study of Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation
Status:
COMPLETED
Status Verified Date:
2018-10
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:
RATIONALE 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 Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving bevacizumab together with erlotinib may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with erlotinib works after radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma
PURPOSE This phase II trial is studying how well giving bevacizumab together with erlotinib works after radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma
Detailed Description:
OBJECTIVES
Primary
To determine the overall survival of patients with newly diagnosed glioblastoma multiforme GBM with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide
Secondary
To determine the 12- and 24-month progression-free survival PFS of patients with newly diagnosed GBM with unmethylated MGMT promoter treated with this regimen
To assess radiographic response rates
To perform correlative tissue assays
To collect safety data on the combination of bevacizumab and erlotinib hydrochloride in patients with newly diagnosed GBM with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide
OUTLINE This is a multicenter study
Patients undergo radiotherapy either intensity-modulated radiation therapy or 3-D conformal radiotherapy once daily 5 days a week and receive oral temozolomide concurrently with radiotherapy once daily for 6 weeks as planned Patients whose tumor has a methylated MGMT promoter are removed from study
Approximately 4 weeks after completion of radiotherapy and temozolomide patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28 Treatment with bevacizumab and erlotinib hydrochloride repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at approximately 30 days and then every 3 months thereafter
Primary
To determine the overall survival of patients with newly diagnosed glioblastoma multiforme GBM with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide
Secondary
To determine the 12- and 24-month progression-free survival PFS of patients with newly diagnosed GBM with unmethylated MGMT promoter treated with this regimen
To assess radiographic response rates
To perform correlative tissue assays
To collect safety data on the combination of bevacizumab and erlotinib hydrochloride in patients with newly diagnosed GBM with unmethylated MGMT promoter treated with bevacizumab and erlotinib hydrochloride after radiotherapy and temozolomide
OUTLINE This is a multicenter study
Patients undergo radiotherapy either intensity-modulated radiation therapy or 3-D conformal radiotherapy once daily 5 days a week and receive oral temozolomide concurrently with radiotherapy once daily for 6 weeks as planned Patients whose tumor has a methylated MGMT promoter are removed from study
Approximately 4 weeks after completion of radiotherapy and temozolomide patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28 Treatment with bevacizumab and erlotinib hydrochloride repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at approximately 30 days and then every 3 months thereafter
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 |
|---|---|---|---|
| STU00002792 | OTHER | Northwestern University IRB | None |
| NU 07C3 | OTHER | None | None |
| BTTC08-01 | OTHER | None | None |