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

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ClinicalTrials.gov Identifier: NCT00322712
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Pancreatic Cancer
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Arm
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
treated with bevacizumab not cetuximab             1
Arm/Group Title Treatment Arm
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  41.7%
>=65 years
7
  58.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
70
(50 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
5
  41.7%
Male
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Time to Death
Hide Description Length of survival of patients treated with a combination of Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week.
Time Frame From date of treatment until time of death
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Arm
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: Months
7
(3 to 18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm
Hide Arm/Group Description 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).
All-Cause Mortality
Treatment Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Arm
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Arm
Affected / at Risk (%)
Total   0/12 (0.00%) 
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
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