Clinical trial NCT00140036: Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).
Official title: Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Correlation of genotype with safety and efficacy measures.
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: Stamford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tamarac
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Terre Haute
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Hooksett
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Rockville Centre
country: United States
facility: Pfizer Investigational Site
state: New York
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hendersonville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston - Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Zanesville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Temple
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Newport News
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Fleurimont
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: