Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma

Phase 2 Completed 74 enrolled University of California, San Francisco

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase II study of Bevacizumab plus Temodar and Tarceva in patients with non-progressive glioblastoma or gliosarcoma. Patients must have stable disease immediately following a standard course of up-front radiotherapy and Temodar. All patients will receive Bevacizumab, Temodar and Tarceva. A total of 60 patients will be enrolled. Our hypothesis is that the combination of Bevacizumab plus Temodar and Tarceva will increase survival over that seen in historical controls who have newly diagnosed, non-progressive glioblastoma or gliosarcoma following radiotherapy plus Temodar and use Temodar alone.

Timeline

Start: 2007-09
Primary completion: 2013-05
Completion: 2013-05

Outcome

Missed primary endpoint

paper did not reach the primary endpoint of improved OS. PMID 24637230 ↗

Publications

Results Clarke JL, Molinaro AM, Phillips JJ, Butowski NA, Chang SM, Perry A, Costello JF, DeSilva AA, Rabbitt JE, Prados MD. A single-institution phase II trial of radiation, temozolomide, erlotinib, and bevacizumab for initial treatment of glioblastoma. Neuro Oncol. 2014 Jul;16(7):984-90. doi: 10.1093/neuonc/nou029.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bevacizumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Erlotinib	Small molecule	100 mg	Oral
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Erlotinib	Small molecule	200 mg	Oral
Subject	Erlotinib	Small molecule	500 mg	Oral
Subject	Erlotinib	Small molecule	600 mg	Oral
Subject	Temozolomide	Small molecule	75 mg/m2	—
Subject	Temozolomide	Small molecule	150 mg/m2	—
Subject	Temozolomide	Small molecule	200 mg/m2	—