27
Participants
Start Date
October 31, 2005
Primary Completion Date
October 31, 2007
Study Completion Date
September 30, 2012
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.
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 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.
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland
National Cancer Institute (NCI)
NIH
David Peereboom
OTHER