Glioblastoma Clinical Trial
Official title:
Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma
Primary objective:
To estimate 6-month progression free survival probability of pts w recurrent malignant
gliomas treated w erlotinib + bevacizumab.
Secondary Objectives:
To evaluate safety & tolerability of erlotinib + bevacizumab among pts w recurrent malignant
gliomas To evaluate radiographic response of pts w recurrent malignant gliomas treated w
erlotinib + bevacizumab To evaluate pharmacokinetics of erlotinib when administered to pts w
recurrent malignant gliomas; & to examine relationship of clinical response to Epidermal
Growth Factor (EGFR) expression, amplification, & v-III mutation, phosphatase and tensin
homolog (PTEN) expression, vascular endothelial growth factor (VEGF) expression, vascular
endothelial growth factor receptor 2 (VEGFR-2) & phosphorylated protein kinase B (PKB/Akt)
in archival tumor samples
Exploratory, Phase II study designed to assess anti-tumor activity of combinatorial regimen
consisting of erlotinib + bevacizumab among pts w recurrent malignant glioma. Signal
transduction inhibitors, such as erlotinib, as well as anti-angiogenic agents, such as
bevacizumab, are expected to exert a cytostatic anti-tumor effect. Primary endpoint of study
is probability of progression-free survival at 6 months. An important secondary objective is
to further assess the safety of erlotinib + bevacizumab for pts w RMG. Pharmacokinetic
studies included in protocol will evaluate impact of enzyme-inducing anti-epileptic drugs
(EIAEDs) on metabolism of erlotinib.
If study demonstrates that combo regimen of erlotinib + bevacizumab is associated w
encouraging anti-tumor activity among pts w recurrent malignant glioma (RMG), further
assessment of regimen in additional ph II & possibly ph III studies, will be considered.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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