NCT00140036

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2002

Typical duration for phase_4

Geographic Reach
2 countries

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

First QC Date

August 29, 2005

Last Update Submit

February 28, 2008

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Correlation of genotype with safety and efficacy measures.

Interventions

Blood drawPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in studies employing treatment with irinotecan and a signed informed consent.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

Location

Pfizer Investigational Site

Tucson, Arizona, 85715, United States

Location

Pfizer Investigational Site

Fresno, California, 93710, United States

Location

Pfizer Investigational Site

Stamford, Connecticut, 06902, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Jacksonville, Florida, 32207, United States

Location

Pfizer Investigational Site

New Port Richey, Florida, 34652, United States

Location

Pfizer Investigational Site

Tamarac, Florida, 33321, United States

Location

Pfizer Investigational Site

Rockford, Illinois, 61108-2472, United States

Location

Pfizer Investigational Site

Terre Haute, Indiana, 47802, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Pfizer Investigational Site

Annapolis, Maryland, 21401, United States

Location

Pfizer Investigational Site

Pittsfield, Massachusetts, 01201, United States

Location

Pfizer Investigational Site

Minneapolis, Minnesota, 55422, United States

Location

Pfizer Investigational Site

Columbia, Missouri, 65212, United States

Location

Pfizer Investigational Site

Billings, Montana, 59101, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89106, United States

Location

Pfizer Investigational Site

Hooksett, New Hampshire, 03106, United States

Location

Pfizer Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

Pfizer Investigational Site

Rockville Centre, New York, 11570, United States

Location

Pfizer Investigational Site

Greenville, North Carolina, 27834, United States

Location

Pfizer Investigational Site

Hendersonville, North Carolina, 28738, United States

Location

Pfizer Investigational Site

Hickory, North Carolina, 28602, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27157, United States

Location

Pfizer Investigational Site

Zanesville, Ohio, 43701, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29406, United States

Location

Pfizer Investigational Site

Temple, Texas, 76508, United States

Location

Pfizer Investigational Site

Newport News, Virginia, 23606, United States

Location

Pfizer Investigational Site

Milwaukee, Wisconsin, 53226, United States

Location

Pfizer Investigational Site

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Pfizer Investigational Site

Kingston, Ontario, K7L 5P9, Canada

Location

Pfizer Investigational Site

Kitchener, Ontario, N2G 1G3, Canada

Location

Pfizer Investigational Site

Windsor, Ontario, Canada

Location

Pfizer Investigational Site

Fleurimont, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

September 1, 2002

Study Completion

August 1, 2005

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

CA(5)US(29)