Ph II Bevacizumab + Etoposide for Pts w Recurrent MG
Recruitment status was Active, not recruiting
Primary Objective to estimate 6-month progression free survival probability of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.
Secondary Objectives To evaluate safety & tolerability of Etoposide + bevacizumab among pts w recurrent malignant glioma.
To evaluate radiographic response, progression free survival & overall survival of pts w recurrent malignant glioma treated w Etoposide + bevacizumab.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma|
- 6 mth progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- a.Radiographic response. b.Median progression free survival and overall survival. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Gr 3 or greater, treatment related, non-hematologic toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Drug: Bevacizumab and Etoposide
- Bevacizumab - Avastin
Exploratory, single-arm, ph II study designed to assess anti-tumor activity of combinatorial regimen consisting of Etoposide + bevacizumab among pts w RMG. Primary endpoint of study is probability of progression-free survival at 6 mths. Important secondary objective is to further assess safety of Etoposide & bevacizumab for pts w RMG.
If study demonstrates that combinatorial regimen of Etoposide + bevacizumab is associated w encouraging anti-tumor activity among pts w RMG, further assessment of regimen in additional ph II & possibly ph III studies, will be considered.
|United States, North Carolina|
|Duke University Health System|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||David A. Reardon, MD||Duke University Health System|