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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00943826
First received: July 17, 2009
Last updated: September 6, 2013
Last verified: September 2013
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Glioblastoma
Interventions: Drug: bevacizumab [Avastin®]
Drug: Placebo
Drug: temozolomide
Radiation: Radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bevacizumab + RT+Temozolomide In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
Placebo + RT+Temozolomide In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression//unacceptable toxicity.

Participant Flow for 3 periods

Period 1:   Concurrent Phase
    Bevacizumab + RT+Temozolomide     Placebo + RT+Temozolomide  
STARTED     458     463  
Received Randomized Treatment     452     459  
COMPLETED     397     421  
NOT COMPLETED     61     42  
Adverse Event                 50                 27  
Withdrew consent                 4                 8  
Refused treatment/Did not cooperate                 4                 6  
Administrative reasons                 2                 1  
Protocol Violation                 1                 0  

Period 2:   Maintenance Phase
    Bevacizumab + RT+Temozolomide     Placebo + RT+Temozolomide  
STARTED     396     370  
COMPLETED     353     329  
NOT COMPLETED     43     41  
Adverse Event                 31                 30  
Withdrew consent                 4                 5  
Refused treatment/Did not cooperate                 4                 3  
Administrative reasons                 4                 2  
Failure to return                 0                 1  

Period 3:   Monotherapy Phase
    Bevacizumab + RT+Temozolomide     Placebo + RT+Temozolomide  
STARTED     269     159  
COMPLETED     218     146  
NOT COMPLETED     51     13  
Adverse Event                 33                 3  
Administrative reasons                 8                 4  
Refused treatment/ Did not cooperate                 5                 2  
Withdrew Consent                 3                 3  
Failure to return                 2                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat population included all randomized participants.

Reporting Groups
  Description
Bevacizumab + RT+Temozolomide In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
Placebo + RT+Temozolomide In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Bevacizumab + RT+Temozolomide     Placebo + RT+Temozolomide     Total  
Number of Participants  
[units: participants]
  458     463     921  
Age  
[units: years]
Mean ( Full Range )
  55.9  
  ( 20 to 84 )  
  55.9  
  ( 18 to 79 )  
  55.9  
  ( 18 to 84 )  
Gender  
[units: participants]
     
Female     176     165     341  
Male     282     298     580  



  Outcome Measures
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1.  Primary:   Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator   [ Time Frame: Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)] ]

2.  Secondary:   Progression-free Survival (PFS) as Assessed by an Independent Review Facility   [ Time Frame: Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)] ]

3.  Secondary:   Percentage of Participants With One-Year Survival   [ Time Frame: 1 year ]

4.  Secondary:   Duration of Stable/Improved Health Related Quality of Life (HRQoL) Using the European Organisation for Research and Treatment of Cancer Scales (EORTC) QLQ-C30 and BN20   [ Time Frame: Randomization until Progressive Free Survival Event [Until data cutoff= 31 March 2012 (up to 34 months)] ]

5.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Death   [ Time Frame: Until data cutoff= 31 March 2012 (up to 34 months) ]

6.  Primary:   Co-Primary: Overall Survival (OS)   [ Time Frame: Randomization until Overall Survival Event ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   No

7.  Secondary:   Percentage of Participants With Two-year Survival   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   02/2014   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche or Genentech, Inc.
phone: 800-821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00943826     History of Changes
Other Study ID Numbers: BO21990, 2008-006146-26
Study First Received: July 17, 2009
Results First Received: March 29, 2013
Last Updated: September 6, 2013
Health Authority: United States: Food and Drug Administration