Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00140036

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms	Procedure: Blood draw	Phase IV

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).

Further study details as provided by Pfizer:

Primary Outcome Measures:

Correlation of genotype with safety and efficacy measures.

Estimated Enrollment:	137
Study Start Date:	September 2002
Estimated Study Completion Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140036

Show 34 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	CPTAIV-0020-366, A5961020
Study First Received:	August 29, 2005
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00140036
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Irinotecan
Colonic Diseases

Leucovorin
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Immunologic Factors
Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009