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

Phase 2 Completed 66 enrolled University of California, San Francisco Genentech, Inc. · collab

NaSingle-groupOpen-labelTreatment

Summary

The patients eligible for this study are those diagnosed with glioblastoma or gliosarcoma who have recently undergone surgery and who have not been treated with radiation therapy or chemotherapy. This is called a phase II study. The purpose of the phase II study is to determine how effective Tarceva plus Temodar plus radiation is in controlling the growth of glioblastoma and gliosarcoma. All patients will receive radiation and Temodar plus Tarceva. There is no "placebo" drug.

Timeline

Start: 2004-08
Primary completion: 2011-03
Completion: 2011-03

Outcome

Met primary endpoint

paper Median survival was 19.3 months in the current study and 14.1 months in the combined historical control studies, with a hazard ratio for survival (treated/control) of 0.64 (95% CI, 0.45 to 0.91). PMID 19075262 ↗

paper Patients treated with the combination of erlotinib and temozolomide during and following radiotherapy had better survival than historical controls. PMID 19075262 ↗

Publications

Results Prados MD, Chang SM, Butowski N, DeBoer R, Parvataneni R, Carliner H, Kabuubi P, Ayers-Ringler J, Rabbitt J, Page M, Fedoroff A, Sneed PK, Berger MS, McDermott MW, Parsa AT, Vandenberg S, James CD, Lamborn KR, Stokoe D, Haas-Kogan DA. Phase II study of erlotinib plus temozolomide during and after radiation therapy in patients with newly diagnosed glioblastoma multiforme or gliosarcoma. J Clin Oncol. 2009 Feb 1;27(4):579-84. doi: 10.1200/JCO.2008.18.9639. Epub 2008 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Erlotinib	Small molecule	300 mg	Oral
Subject	Temozolomide	Small molecule	200 mg/m2	—