Status:
COMPLETED
Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 \& tole...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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 entry;
- If sexually active, pts must agree to take contraceptive measures for duration of treatments
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00671970
Start Date
February 1 2007
End Date
April 1 2010
Last Update
May 13 2013
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710