Phase I/II Study of Panitumumab, Capecitabine and Oxaliplatin w EBRT for Esophageal Cancer (POXX)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Brian Czito, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00578071
First received: December 18, 2007
Last updated: January 20, 2013
Last verified: January 2013
Results First Received: April 10, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer of the Esophagus
Interventions: Drug: Panitumumab
Drug: Capecitabine
Drug: Oxaliplatin
Radiation: Radiation Therapy (RT)

  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 Panitumumab, oxiplatin, capecitabine, radiation therapy

Participant Flow:   Overall Study
    Chemoradiation  
STARTED     29  
COMPLETED     29  
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 Panitumumab, oxiplatin, capecitabine, radiation therapy

Baseline Measures
    Chemoradiation  
Number of Participants  
[units: participants]
  29  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  58.97  ± 10.32  
Gender  
[units: participants]
 
Female     1  
Male     28  
Region of Enrollment  
[units: participants]
 
United States     29  



  Outcome Measures
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1.  Primary:   Panitumumab Maximum Tolerated Dose in Milligrams (mg)   [ Time Frame: 60 days ]

2.  Primary:   Number of Participants With Dose-limiting Toxicities (DLTs)   [ Time Frame: Within 30 days of the last day of radiation ]

3.  Secondary:   Pathological Complete Response Rates Associated With This Regimen.   [ Time Frame: 90 days ]

4.  Secondary:   Describe the 2 Year Overall Survival Rates for the Patients Studied on This Protocol.   [ Time Frame: 2 yrs ]
Results not yet reported.   Anticipated Reporting Date:   05/2013   Safety Issue:   No


  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: Dr Brian Czito
Organization: Duke University Medical Center Radiation Oncology
phone: 668-7336
e-mail: brian.czito@duke.edu


No publications provided


Responsible Party: Brian Czito, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00578071     History of Changes
Other Study ID Numbers: Pro00002207, SPS 151596
Study First Received: December 18, 2007
Results First Received: April 10, 2012
Last Updated: January 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board