Overview

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

Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Bevacizumab
Irinotecan
Temozolomide
Criteria
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.