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Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma

Phase 2
18 Years
Not Enrolling
Glioblastoma, Gliosarcoma

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Trial Information

Phase II Trial of Bevacizumab Plus Erlotinib for Patients With Recurrent Malignant Glioma

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.

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 external beam radiation therapy (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, absolute neutrophil count (ANC) >1,500 cells/microliter,
platelets >100,000 cells/microliter

- Serum creatinine <.5mg/dl, blood urea nitrogen (BUN) <25 mg/dl, serum glutamate
oxaloacetate transaminase (SGOT) & bilirubin <1.5 x upper limit of normal (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 Institutional Review Board (IRB) prior to patient

- If sexually active, pts must agree to take contraceptive measures for duration of

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 central nervous system (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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 Month Progression-free Survival

Outcome Description:

The proportion of patients alive and progression free at 6 months

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Health System


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

April 2010

Related Keywords:

  • Glioblastoma
  • Gliosarcoma
  • Glioblastoma
  • Gliosarcoma
  • Recurrent MG
  • Malignant glioma
  • Glioma
  • Glioblastoma multiforme (GBM)
  • GBM
  • Brain tumor
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • Bevacizumab
  • Avastin
  • Erlotinib
  • Tarceva
  • Glioblastoma
  • Glioma
  • Gliosarcoma



Duke University Health System Durham, North Carolina  27705