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Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas

This study has been completed.
Sponsor:
Collaborators:
Genentech
Schering-Plough
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00612339
First received: January 29, 2008
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
Results First Received: August 9, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma
Gliosarcoma
Intervention: Drug: Avastin and Temozolomide

  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
Subjects were accrued between October 2007 and September 2008 within the clinic at Duke Comprehensive Cancer Center.

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
Avastin and Temozolomide Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.

Participant Flow:   Overall Study
    Avastin and Temozolomide  
STARTED     41  
COMPLETED     41  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Avastin and Temozolomide Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.

Baseline Measures
    Avastin and Temozolomide  
Number of Participants  
[units: participants]
 		  41  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     32  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation 		  58.6  ± 7.6  
Gender  
[units: participants]
 		 
Female     15  
Male     26  



  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 4 months ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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: Katherine Peters, MD, PhD
Organization: Duke University Medical Center
phone: 9196846173
e-mail: katherine.peters@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00612339     History of Changes
Other Study ID Numbers: 00001022
Study First Received: January 29, 2008
Results First Received: August 9, 2012
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board