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

This study has been completed.
Information provided by (Responsible Party):
Brian Czito, Duke University Medical Center Identifier:
First received: December 18, 2007
Last updated: May 22, 2015
Last verified: May 2015
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
Chemoradiation Panitumumab, oxiplatin, capecitabine, radiation therapy

Participant Flow:   Overall Study
STARTED     29  
COMPLETED     29  

  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
Chemoradiation Panitumumab, oxiplatin, capecitabine, radiation therapy

Baseline Measures
Number of Participants  
[units: participants]
[units: participants]
<=18 years     0  
Between 18 and 65 years     23  
>=65 years     6  
[units: years]
Mean (Standard Deviation)
  58.97  (10.32)  
[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:   Overall Survival Rates for the Patients Studied on This Protocol.   [ Time Frame: One year ]

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

  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

No publications provided

Responsible Party: Brian Czito, Duke University Medical Center 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: May 22, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board