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Phase II Study of Irinotecan and Panitumumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00836277
First Posted: February 4, 2009
Last Update Posted: November 15, 2016
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.
Collaborator:
Amgen
Information provided by (Responsible Party):
Weijing Sun, MD, FACP, University of Pittsburgh
Results First Submitted: July 27, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Esophageal Cancer
Interventions: Drug: Panitumumab
Drug: Irinotecan

  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
Irinotecan + Panitumumab Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.

Participant Flow:   Overall Study
    Irinotecan + Panitumumab
STARTED   24 
COMPLETED   18 
NOT COMPLETED   6 
Not evaluable for response                6 



  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
Irinotecan + Panitumumab Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.

Baseline Measures
   Irinotecan + Panitumumab 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Years]
Median (Full Range)
 62.5 
 (33 to 79) 
Gender 
[Units: Participants]
 
Female   3 
Male   15 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   18 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
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1.  Primary:   Response Rate (RR)   [ Time Frame: Up to 14 months ]

2.  Primary:   Clinical Benefit Rate (CBR)   [ Time Frame: Up to 14 months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 45 months (cohort) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 45 months (cohort) ]

5.  Secondary:   1-year (Overall) Survival Rate   [ Time Frame: 1 year ]


  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: Weijing Sun, MD
Organization: University of Pittsburgh Cancer Institute
phone: 412-864-7764
e-mail: sunw@upmc.edu



Responsible Party: Weijing Sun, MD, FACP, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00836277     History of Changes
Other Study ID Numbers: 07-161
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: July 27, 2016
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2016