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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00578071
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : August 7, 2012
Last Update Posted : July 2, 2015
Information provided by (Responsible Party):
Brian Czito, Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cancer of the Esophagus
Interventions: Drug: Panitumumab
Drug: Capecitabine
Drug: Oxaliplatin
Radiation: Radiation Therapy (RT)

  Participant Flow

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

  Baseline Characteristics

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
Overall Participants Analyzed 
[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

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

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

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

Responsible Party: Brian Czito, Duke University Identifier: NCT00578071     History of Changes
Other Study ID Numbers: Pro00002207
SPS 151596
First Submitted: December 18, 2007
First Posted: December 20, 2007
Results First Submitted: April 10, 2012
Results First Posted: August 7, 2012
Last Update Posted: July 2, 2015