Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG)

PHASE2CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

November 30, 2008

Study Completion Date

April 30, 2010

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Bevacizumab and Erlotinib

"Bevacizumab administered intravenously at dose 10 mg/kg every 2 wks. Erlotinib administered orally, continuously once daily in fasting state for each 42-day cycle. Dose of erlotinib is based on prior erlotinib monotherapy trial in RMG. It will be 200 mg/day for pts not on cytochrome P450 3A4 (CYP3A4)-enzyme inducing anti-epileptic drugs \& 500 mg/day for pts on EIAEDs.~It is possible that taking erlotinib w regular medications or supplements may change how erlotinib, subject's regular medications, or subject's regular supplements work. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent."

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Duke University

OTHER

NCT00671970 - Phase (Ph) II Bevacizumab + Erlotinib for Patients (Pts) With Recurrent Malignant Glioma (MG) | Biotech Hunter | Biotech Hunter