A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme
- Determine the progression-free survival and overall survival of patients with newly
diagnosed glioblastoma multiforme treated with adjuvant radiotherapy, temozolomide, and
- Evaluate the toxicity of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive oral temozolomide once daily on days 1-42 and undergo concurrent
radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Four weeks after
completion of radiotherapy and temozolomide, patients receive oral temozolomide once daily
on days 1-5. Treatment with temozolomide repeats every 28 days for up to 12 courses in the
absence of disease progression or unacceptable toxicity. Patients also receive oral
erlotinib hydrochloride once daily beginning on day 1 of radiotherapy and continuing in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
at 6 months
David M. Peereboom, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Federal Government
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|