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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT00943826
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.
  • Temozolomide — DRUG
    75 mg/m\^2 once daily for 6 weeks, followed by 150-200 mg/m\^2 once daily on days 1-5 of six 4 week cycles.
  • Radiation therapy — RADIATION
    30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.
  • Placebo — DRUG
    Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.

Study Details

This 2 arm study investigated the efficacy and safety of the addition of bevacizumab 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. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously \[IV\] once every 2 week \[q2w\]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray \[Gy\], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared \[mg/m\^2\] oral administration \[po\] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m\^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks \[q3w\]) or placebo monotherapy continued. The time on study treatment was until disease progression.

Key Dates

First listed
Jul 22, 2009
Start date
Jun 29, 2009
Status verified
Aug 2017
Primary completion
Feb 28, 2013
Completion
Sep 9, 2015

Study Design

Enrollment
921 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + RT + Temozolomide
    In the Concurrent Phase participants will receive radiotherapy (RT) in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and bevacizumab 10 mg/kg IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they receive six 28-day cycle of bevacizumab 10 mg/kg IV q2w and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive bevacizumab 15 mg/kg IV q3w until disease progression/unacceptable toxicity.
  • Placebo Comparator: Placebo + RT + Temozolomide
    In the Concurrent Phase participants will receive radiotherapy in daily fractions of 2 Gy to be given 5 days per week for 6 weeks and temozolomide 75 mg/m\^2 daily from the first day to the last day of radiotherapy (it may continue for a maximum of 49 days in case of delay to the end of radiation therapy) and placebo IV every 2 weeks for 6 weeks. There will be a 4 week treatment break. Participants will then enter the Maintenance Phase where they will receive six 28-day cycle of placebo IV q2w and temozolomide 150 to 200 mg/m\^2 daily in the first 5 days of each cycle. The participants will then enter the Monotherapy Phase where they will receive placebo IV q3w until disease progression/unacceptable toxicity.

Primary Outcome Measure

Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator [ Time Frame: Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months) ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham; Neuro-OncologyBirminghamAlabama35294-
UCLALos AngelesCalifornia90095-
University of ColoradoAuroraColorado80045-
Moffitt Cancer CenterTampaFlorida33612-
Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care CtrEvanstonIllinois60201-
Henry Ford Health SystemDetroitMichigan48202-
Hatton Research InstitutesCincinnatiOhio45220-
Sarah Cannon Cancer Center and Research InstituteNashvilleTennessee37203-
University of VirginaCharlottesvilleVirginia22908-

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Alabama At Birmingham; Neuro-Oncology· Birmingham, ALUCLA· Los Angeles, CAUniversity of Colorado· Aurora, COMoffitt Cancer Center· Tampa, FLOncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr· Evanston, ILHenry Ford Health System· Detroit, MI

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