Expired Study
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Durham, North Carolina 27710


Purpose:

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 EGFR expression, amplification, & v-III mutation, PTEN expression, VEGF expression & phosphorylated PKB/Akt in archival tumor samples


Study summary:

Exploratory, ph 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 EIAEDs on metabolism of erlotinib. If study demonstrates that combo regimen of erlotinib + 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.


Criteria:

Inclusion Criteria: - Pts have histologically confirmed diagnosis of recurrent/progressive WHO gr III & IV MG & meet following inclusion criteria: - Age >18 yrs - Interval of >4 wks since prior surgery - Interval of >4 wks since prior XRT or chemo, unless there is unequivocal evidence of progressive disease & pts have recovered from all anticipated toxicity of most recent therapy - Karnofsky performance status score >60 - Hematocrit > 29 percent, ANC >1,500 cells/microliter, platelets >100,000 cells/microliter - Serum creatinine <.5mg/dl, BUN <25 mg/dl, serum SGOT & bilirubin <1.5 x ULN - For pts on corticosteroids, they have been on stable dose for 1 wk prior to entry - Pts have had prior bevacizumab are eligible however interval of >6 wks must have elapsed since their last dose - Signed informed consent approved by IRB prior to patient entry; - If sexually active, pts must agree to take contraceptive measures for duration of treatments Exclusion Criteria: - Prior therapy w either bevacizumab/EGFR-directed agents - >3 prior recurrences - Pregnancy/breast feeding - Co-medication w immuno-suppressive agents other than corticosteroids including but not limited to cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil - Evidence of CNS hemorrhage on baseline MRI on CT scan - Pts who require therapeutic anti-coagulation - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics & psychiatric illness/social situations that would limit compliance w study requirements, or disorders associated w significant immunocompromised state - Pts w another primary malignancy that has required treatment within past year - Pts w acute/chronic renal insufficiency/those w acute renal insufficiency of any severity due to hepato-renal syndrome/in peri-operative liver transplantation period


NCT ID:

NCT00671970


Primary Contact:

Principal Investigator
David A. Reardon, MD
Duke University Health System


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27710
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 23, 2018

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