Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas

PHASE2CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

August 31, 2011

Study Completion Date

May 31, 2013

Conditions
GlioblastomaGliosarcomaBrain Tumor
Interventions
DRUG

Avastin

Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.

DRUG

Temozolomide

Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.

RADIATION

Radiation Therapy (XRT)

Treatment with standard XRT (radiation) for 6.5 weeks.

DRUG

Irinotecan

Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors
All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Schering-Plough

INDUSTRY

lead

Duke University

OTHER

NCT00597402 - Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas | Biotech Hunter | Biotech Hunter