Phase II Study of Bevacizumab Plus Either Temozolomide or Etoposide for (GBM) Patients Who Have Failed Bevacizumab Plus Irinotecan
This is exploratory, two-arm, phase II study designed to assess anti-tumor activity of bev +
either daily temozolomide/etoposide among GBM pts w progressive disease following bev +
irinotecan. About 48 participants w recurrent GBM will take part in this study.
Approximately 24 participants will receive bev plus temozolomide & approximately 24 will
receive bev + etoposide. Pts must have confirmed diagnosis of GBM & radiographic evidence of
recurrence following prior therapy bev + irinotecan. 24 pts will be enrolled onto each arm
of this single-stage study. If 4 or more of these 24 pts live 6/more months without disease
progression, treatment regimen will be considered worthy of further investigation.
Otherwise, treatment regimen will be determined not worthy of further investigation within
pt population. Type I & II error rates associated w testing are 0.030 & 0.115 respectively.
Management guidelines dose reduction/interruption for temo, etoposide, & bev.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The Primary Outcome Measure is 6 Month Progression-free Survival.
Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or to death due to any cause.
David A. Reardon, MD
Duke University Health System
United States: Institutional Review Board
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