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


Tracking Information

Start Date  ICMJEJune 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
  • Overall survival [ Time Frame: Assessments in weeks 10,18, 26 and 34 and at 9-weekly intervals thereafter ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Assessments in weeks 10,18, 26 and 34 and at 9-weekly intervals thereafter ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00943826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 21, 2009)
  • Survival rates [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Assessments in weeks 10, 18, 26 and 34 and at 9-weekly intervals thereafter ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Avastin (Bevacizumab) in Combination With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma
Official Title  ICMJEA Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Bevacizumab, Radiotherapy and Temozolomide (TMZ) Followed by Bevacizumab and TMZ, Versus Placebo Radiotherapy and TMZ Followed by Placebo and TMZ on Survival in Patients With Newly Diagnosed Glioblastoma
Brief Summary

This 2 arm study will investigate 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 will be randomly assigned to either the Avastin (10mg/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 (75mg/m2po daily) for 6 weeks.After a 4 week treatment break,patients will continue to receive Avastin (10mg/kg iv q2w) or placebo, plus temozolomide (150-200mg/m2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment. Following the maintenance phase,Avastin (15mg/kg iv q3w) or placebo monotherapy will continue. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEGlioblastoma
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    10mg/kg iv q2w
  • Drug: Placebo
    iv q2w
  • Drug: temozolomide
    75mg/m2 po once daily for 6 weeks, followed by 150-200mg/m2 po daily on days 1-5 of each 6 x 4 week cycle
  • Radiation: Radiation therapy
    30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks
Study Arms / Comparison Groups
  • 1: Experimental
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: temozolomide
    • Radiation: Radiation therapy
  • 2: Placebo Comparator
    Interventions:
    • Drug: Placebo
    • Drug: temozolomide
    • Radiation: Radiation therapy

Recruitment Information

Estimated Enrollment  ICMJE920
Estimated Completion DateOctober 2014
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • newly diagnosed glioblastoma;
  • WHO performance status <=2;
  • stable or decreasing corticosteroid dose within 5 days prior to randomization.

Exclusion Criteria:

  • evidence of recent hemorrhage or postoperative 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 MGMT status for enrollment into a clinical trial.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Please reference Study ID Number: BO21990973-235-5000
Contact: or800-526-6367 (FOR US ONLY)
Location Countries  ICMJEUnited States,   Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00943826
Responsible PartyClinical Trials, Study Director, Hoffmann-La Roche
Study ID Numbers  ICMJEBO21990, 2008-006146-26
Study Sponsor  ICMJEHoffmann-La Roche
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Clinical TrialsHoffmann-La Roche, +1 973 235 5000
Information Provided ByHoffmann-La Roche