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INST 0603C Patients With Unresectable/Metastatic Pancreatic Cancer Treated in the UNM Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322712
First Posted: May 8, 2006
Last Update Posted: March 4, 2015
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.
Information provided by (Responsible Party):
University of New Mexico
Results First Submitted: February 11, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Pancreatic Cancer

  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
Treatment Arm Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).

Participant Flow:   Overall Study
    Treatment Arm
STARTED   12 
COMPLETED   11 
NOT COMPLETED   1 
treated with bevacizumab not cetuximab                1 



  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
Treatment Arm Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).

Baseline Measures
   Treatment Arm 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   7 
Age 
[Units: Years]
Median (Full Range)
 70 
 (50 to 82) 
Gender 
[Units: Participants]
 
Female   5 
Male   7 
Region of Enrollment 
[Units: Participants]
 
United States   12 


  Outcome Measures

1.  Primary:   Time to Death   [ Time Frame: From date of treatment until time of death ]


  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. Fa Chyi Lee
Organization: University of New Mexico
phone: 505-925-0405
e-mail: flee@salud.unm.edu



Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00322712     History of Changes
Other Study ID Numbers: INST 0603C
First Submitted: May 5, 2006
First Posted: May 8, 2006
Results First Submitted: February 11, 2015
Results First Posted: March 4, 2015
Last Update Posted: March 4, 2015