Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors

PHASE2CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Glioblastoma MultiformeGliosarcoma
Interventions
DRUG

Tarceva

Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status

DRUG

Temodar

Temodar 200 mg/m\^2/day x 5 days every 28 days

PROCEDURE

Radiation Therapy

Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.

Trial Locations (1)

94143-0372

UCSF Department of Neurological Surgery, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

University of California, San Francisco

OTHER

NCT00187486 - Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors | Biotech Hunter | Biotech Hunter