- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140036
Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).
February 28, 2008 updated by: Pfizer
This protocol describes procedures for the collection of blood samples for the intent of determining genetic contribution to the safety and efficacy of CPT/FU/LV.
Study Overview
Study Type
Interventional
Enrollment
137
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2E2
- Pfizer Investigational Site
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Ontario
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Kingston, Ontario, Canada, K7L 5P9
- Pfizer Investigational Site
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Kitchener, Ontario, Canada, N2G 1G3
- Pfizer Investigational Site
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Windsor, Ontario, Canada
- Pfizer Investigational Site
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- Pfizer Investigational Site
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Alabama
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Mobile, Alabama, United States, 36608
- Pfizer Investigational Site
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Arizona
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Tucson, Arizona, United States, 85715
- Pfizer Investigational Site
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California
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Fresno, California, United States, 93710
- Pfizer Investigational Site
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Connecticut
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Stamford, Connecticut, United States, 06902
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Pfizer Investigational Site
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Florida
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Jacksonville, Florida, United States, 32207
- Pfizer Investigational Site
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New Port Richey, Florida, United States, 34652
- Pfizer Investigational Site
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Tamarac, Florida, United States, 33321
- Pfizer Investigational Site
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Illinois
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Rockford, Illinois, United States, 61108-2472
- Pfizer Investigational Site
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Indiana
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Terre Haute, Indiana, United States, 47802
- Pfizer Investigational Site
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Louisiana
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New Orleans, Louisiana, United States, 70115
- Pfizer Investigational Site
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Maryland
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Annapolis, Maryland, United States, 21401
- Pfizer Investigational Site
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Massachusetts
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Pittsfield, Massachusetts, United States, 01201
- Pfizer Investigational Site
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Minnesota
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Minneapolis, Minnesota, United States, 55422
- Pfizer Investigational Site
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Missouri
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Columbia, Missouri, United States, 65212
- Pfizer Investigational Site
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Montana
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Billings, Montana, United States, 59101
- Pfizer Investigational Site
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Nevada
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Las Vegas, Nevada, United States, 89106
- Pfizer Investigational Site
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New Hampshire
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Hooksett, New Hampshire, United States, 03106
- Pfizer Investigational Site
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Lebanon, New Hampshire, United States, 03756
- Pfizer Investigational Site
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New York
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Rockville Centre, New York, United States, 11570
- Pfizer Investigational Site
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North Carolina
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Greenville, North Carolina, United States, 27834
- Pfizer Investigational Site
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Hendersonville, North Carolina, United States, 28738
- Pfizer Investigational Site
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Hickory, North Carolina, United States, 28602
- Pfizer Investigational Site
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Winston - Salem, North Carolina, United States, 27157
- Pfizer Investigational Site
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Ohio
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Zanesville, Ohio, United States, 43701
- Pfizer Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29406
- Pfizer Investigational Site
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Texas
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Temple, Texas, United States, 76508
- Pfizer Investigational Site
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Virginia
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Newport News, Virginia, United States, 23606
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participation in studies employing treatment with irinotecan and a signed informed consent.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Correlation of genotype with safety and efficacy measures.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2002
Study Completion
August 1, 2005
Study Registration Dates
First Submitted
August 29, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
August 31, 2005
Study Record Updates
Last Update Posted (Estimate)
March 3, 2008
Last Update Submitted That Met QC Criteria
February 28, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPTAIV-0020-366
- A5961020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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