Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 30, 2009

Primary Completion Date

July 31, 2012

Study Completion Date

November 2, 2021

Conditions
Malignant GliomaGlioblastomaGliosarcoma
Interventions
DRUG

Bevacizumab

Bevacizumab (Avastin) at 10 mg/kg every other week during standard radiation therapy (XRT). Following XRT, bevacizumab will remain at 10 mg/kg every other week.

DRUG

Temozolomide

Daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation therapy (XRT). Following XRT, temozolomide will be dosed at 150 mg/m2 daily the first 5 days of each 28-day cycle.

RADIATION

Radiation Therapy (XRT)

Standard radiation therapy for approximately 6.5 weeks

DRUG

Topotecan

Following standard radiation therapy, patients will receive topotecan on days 2 through 6 of each 28-day cycle at a dose of 1.5 mg/m2 for patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs) and 2.0 mg/m2 for patients taking EIAEDs.

Trial Locations (1)

27710

The Preston Robert Tisch Brain Tumor Center at Duke, Durham

Sponsors
All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

GlaxoSmithKline

INDUSTRY

lead

Duke University

OTHER