Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

October 31, 2007

Study Completion Date

September 30, 2012

Conditions
CNS Tumor, Adult
Interventions
DRUG

erlotinib hydrochloride

Erlotinib is available as 25 mg, 100 mg, and 150 mg tablets. It should be administered orally once daily at the prescribed dose specified in the clinical study protocol per dose escalation schema. Preferably, erlotinib should be taken in the morning with up to 200 mL of water at least 1 hour before or 2 hours after a meal.

DRUG

temozolomide

TMZ is supplied in white opaque, preservative-free, two piece hard gelatin capsules of the following sizes: 100mg capsules, 20mg capsules, and 5mg capsules. TMZ will be a once a day orally administered (75 mg/m2 x BSA x 42 days)set of capsules taken at least two hours after and one hour before a meal.

RADIATION

radiation therapy

Concomitant focal RT will be delivered once daily at 2 Gy per fraction, 5 d/wk, for a total of 60 Gy. (6 weeks) as mentioned in therapeutic modalities.

Trial Locations (1)

44195

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

David Peereboom

OTHER

NCT00274833 - Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme | Biotech Hunter | Biotech Hunter