Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma (TART)

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00735306
First received: August 13, 2008
Last updated: May 21, 2013
Last verified: December 2011
Results First Received: October 14, 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: Avastin
Drug: Tarceva
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
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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
Chemoradiation Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.

Participant Flow:   Overall Study
    Chemoradiation  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     0  



  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
Chemoradiation Avastin 10 mg/kg intravenous infusion day 1, 15 and 29 and Tarceva 100, 125 or 150 mg once daily by mouth and Radiation Therapy Mon-Fri for 28 treatments.

Baseline Measures
    Chemoradiation  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     2  
Gender  
[units: participants]
 
Female     5  
Male     7  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     11  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Tarceva Maximum Tolerated Dose in mg   [ Time Frame: 1 yr ]

2.  Secondary:   Number of Dose Limiting Toxicities   [ Time Frame: Within 30 days of completing radiation ]

3.  Secondary:   Overall Survival   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   12/2011   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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
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Results Point of Contact:  
Name/Title: Dr. Brian Czito
Organization: Duke University
phone: 919-668-7336
e-mail: brian.czito@duke.edu


No publications provided


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00735306     History of Changes
Other Study ID Numbers: Pro00001597
Study First Received: August 13, 2008
Results First Received: October 14, 2011
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board