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Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187486
First received: September 13, 2005
Last updated: September 26, 2012
Last verified: September 2012
Results First Received: April 25, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Glioblastoma Multiforme
Gliosarcoma
Interventions: Drug: Tarceva
Drug: Temodar
Procedure: 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
66 patients enrolled from 10/2004 - 2/2006. Patients were enrolled at the UCSF Neuro-Oncology clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Temodar Plus Tarceva Plus Radiotherapy All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs

Participant Flow:   Overall Study
    Temodar Plus Tarceva Plus Radiotherapy
STARTED   66 
COMPLETED   65 
NOT COMPLETED   1 
Protocol Violation                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.
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Reporting Groups
  Description
Temodar Plus Tarceva Plus Radiotherapy All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs

Baseline Measures
   Temodar Plus Tarceva Plus Radiotherapy 
Overall Participants Analyzed 
[Units: Participants]
 66 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   55 
>=65 years   11 
Age 
[Units: Years]
Mean (Standard Deviation)
 54  (11) 
Gender 
[Units: Participants]
 
Female   24 
Male   42 
Region of Enrollment 
[Units: Participants]
 
United States   66 


  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: assessment of survival was every 2 months, up to 181 weeks ]

2.  Secondary:   Progression Free Survival   [ Time Frame: every 2 months measure by MR imaging, up to 39 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Prados, MD
Organization: University of California San Francisco
phone: 415 353 2076
e-mail: PradosM@neurosurg.ucsf.edu


Publications of Results:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187486     History of Changes
Other Study ID Numbers: CC 04101
OSI 2725s ( Other Identifier: Genentech, Inc )
Study First Received: September 13, 2005
Results First Received: April 25, 2011
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration