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

Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma

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.

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Diagnosis of recurrent glioblastoma multiforme (Grade IV)
• Previous treatment with temozolomide and radiotherapy
• First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
• Adequate hematological, biochemical and organ functions

Exclusion Criteria:

• Previous treatment with Avastin or other anti-angiogenic drugs
• Residual relevant toxicity resulting from previous therapy
• Radiotherapy within the 3 months prior to the diagnosis of disease progression
• Chemotherapy in the previous 4 weeks
• Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
• Clinically significant cardiovascular diseases