Overview
A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma
Status:
Completed
Completed
Trial end date:
2014-09-01
2014-09-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
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.