What is involved?
This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Patients receive oral temozolomide and irinotecan hydrochloride IV over 90 minutes on days 1-5.
Patients receive oral temozolomide and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.