A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma

This 2 arm study will compare the effect of Avastin + irinotecan versus temozolomide, in combination with conventional involved field radiotherapy, in patients with newly diagnosed glioblastoma and a non-methylated MGMT promoter. Patients will be randomized 3:1 to receive Avastin 10mg/kg iv every 2 weeks + irinotecan 125mg/m2 iv every 2 weeks, or temozolomide 75mg/m2 po daily during radiotherapy followed by 6 cycles of temozolomide 150-200mg/m2 po daily on days 1-5 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients, 18-70 years of age;
• glioblastoma, confirmed histologically;
• no previous chemotherapy or radiotherapy for glioblastoma;
• non-methylated MGMT promoter in the tumor.

Exclusion Criteria:

• prior systemic treatment for glioblastoma multiforme;
• prior treatment with Avastin;
• significant cardiovascular disease;
• other active malignant disease.