|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||BO21990|
This 2 arm study investigated the efficacy and safety of the addition of bevacizumab (Avastin®) to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Patients were randomly assigned to either the Avastin® (10 mg/kg iv q2w) or the placebo arm, in combination with radiation therapy (total dose 60 Gy, administered as 2 Gy fractions, 5 days/week)plus temozolomide (75 mg/m2 po daily) for 6 weeks. After a 4 week treatment break, patients continued to receive Avastin® (10 mg/kg iv q2w) or placebo, plus temozolomide (150-200 mg/m2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment. Following the maintenance phase, Avastin® (15 mg/kg iv q3w) or placebo monotherapy was continued. The anticipated time on study treatment was until disease progression/unacceptable toxicity.
- adult patients, >=18 years of age;
- newly diagnosed glioblastoma;
- World Health Organization (WHO) performance status <=2;
- stable or decreasing corticosteroid dose within 5 days prior to randomization.
- evidence of recent hemorrhage or postoperative magnetic resonance imaging (MRI) of brain;
- any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas;
- any prior radiotherapy to brain;
- clinically significant cardiovascular disease;
- history of >=grade 2 hemoptysis within 1 month prior to randomization;
- previous centralized screening for Methylguanine-DNA methyltransferase (MGMT) status for enrollment into a clinical trial.
Trial Lead Organizations/Sponsors
F. Hoffmann - La Roche, Limited
|Clinical Trials||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00943826
ClinicalTrials.gov processed this data on October 17, 2013
Back to Top