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Study of Gemcitabine and Erlotinib Plus Sorafenib (GES) in Metastatic Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Desert Regional Medical center
Bayer
OSI Pharmaceuticals
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00696696
First received: June 11, 2008
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
Results First Received: November 18, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Gemcitabine
Drug: Erlotinib
Drug: Sorafenib

  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
The study enrolled 45 patients from September 2007 to May 2010 at New York University Medical center and affiliated hospital, New York, NY and Desert Regional Medical center, Palm Springs, CA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient was enrolled but then withdrew consent before treatment.

Reporting Groups
  Description
Combination GES Combination of Gemcitabine, Erlotinib, and Sorafenib

Participant Flow:   Overall Study
    Combination GES  
STARTED     44  
COMPLETED     26 [1]
NOT COMPLETED     18  
Adverse Event                 5  
Withdrawal by Subject                 8  
Physician Decision                 2  
Death                 3  
[1] number of patients off treatment due to progression of disease only



  Baseline Characteristics
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Reporting Groups
  Description
Combination GES Combination of Gemcitabine, Erlotinib, and Sorafenib

Baseline Measures
    Combination GES  
Number of Participants  
[units: participants]
 		  45  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     22  
Age  
[units: years]
Median ( Full Range ) 		  64  
  ( 45 to 84 )  
Gender  
[units: participants]
 		 
Female     13  
Male     32  
Region of Enrollment  
[units: participants]
 		 
United States     45  



  Outcome Measures
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1.  Primary:   4-month Progression Free Survival (PFS) Rate   [ Time Frame: 4 months ]
  Show Outcome Measure 1

2.  Secondary:   Objective Response Rate   [ Time Frame: up to 1 year ]
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3.  Secondary:   Median Overall Survival (mOS)   [ Time Frame: up to 2 years ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: Deirdre Cohen, MD
Organization: NYU Cancer Institute
phone: 212-731-5656
e-mail: deirdre.cohen@nyumc.org


Publications:


Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00696696     History of Changes
Other Study ID Numbers: NYU 06-882
Study First Received: June 11, 2008
Results First Received: November 18, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration