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Clinical Trials (PDQ®)

A Study of Avastin® (Bevacizumab) in Combination With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overPharmaceutical / IndustryBO21990
2008-006146-26, NCT00943826

Trial Description

Summary

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.

Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical TrialsStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00943826
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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