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

Phase 4

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00140036
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2005-08
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-28
• Last Update Posted: 2008-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Correlation of genotype with safety and efficacy measures.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Fleurimont, Quebec, Canada