A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

Summary

This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.

Timeline

Start

2011-11

Primary completion

2013-12

Completion

2013-12

Publications

• Brandes AA, Finocchiaro G, Zagonel V, Reni M, Caserta C, Fabi A, Clavarezza M, Maiello E, Eoli M, Lombardi G, Monteforte M, Proietti E, Agati R, Eusebi V, Franceschi E. AVAREG: a phase II, randomized, noncomparative study of fotemustine or bevacizumab for patients with recurrent glioblastoma. Neuro Oncol. 2016 Sep;18(9):1304-12. doi: 10.1093/neuonc/now035. Epub 2016 Mar 6.

Drugs

Indications