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

Status

Completed

Intervention / Treatment

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

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E2
        • Pfizer Investigational Site
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
        • Pfizer Investigational Site
      • Kitchener, Ontario, Canada, N2G 1G3
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada
        • Pfizer Investigational Site
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Pfizer Investigational Site
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Tamarac, Florida, United States, 33321
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61108-2472
        • Pfizer Investigational Site
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Pfizer Investigational Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • Pfizer Investigational Site
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New York
      • Rockville Centre, New York, United States, 11570
        • Pfizer Investigational Site
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Pfizer Investigational Site
      • Hendersonville, North Carolina, United States, 28738
        • Pfizer Investigational Site
      • Hickory, North Carolina, United States, 28602
        • Pfizer Investigational Site
      • Winston - Salem, North Carolina, United States, 27157
        • Pfizer Investigational Site
    • Ohio
      • Zanesville, Ohio, United States, 43701
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
    • Texas
      • Temple, Texas, United States, 76508
        • Pfizer Investigational Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site

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
Correlation of genotype with safety and efficacy measures.

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

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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