Colorectal NeoplasmsPhase 4NCT00140036
Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).
A Phase 4 study testing Blood draw in people with Colorectal Neoplasms, run by Pfizer at 34 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 137 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Sep 2002to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in studies employing treatment with irinotecan and a signed informed consent.
Who cannot join
- None.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States29 sites
Pfizer Investigational Site
Annapolis, Maryland, 21401
Pfizer Investigational Site
Billings, Montana, 59101
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Columbia, Missouri, 65212
Pfizer Investigational Site
Fresno, California, 93710
Pfizer Investigational Site
Greenville, North Carolina, 27834
Pfizer Investigational Site
Hendersonville, North Carolina, 28738
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Hooksett, New Hampshire, 03106
Pfizer Investigational Site
Jacksonville, Florida, 32207
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Lebanon, New Hampshire, 03756
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
Minneapolis, Minnesota, 55422
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
New Orleans, Louisiana, 70115
Pfizer Investigational Site
New Port Richey, Florida, 34652
Pfizer Investigational Site
Newport News, Virginia, 23606
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Rockford, Illinois, 61108-2472
Pfizer Investigational Site
Rockville Centre, New York, 11570
Pfizer Investigational Site
Stamford, Connecticut, 06902
Pfizer Investigational Site
Tamarac, Florida, 33321
Pfizer Investigational Site
Temple, Texas, 76508
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Tucson, Arizona, 85715
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
Winston-Salem, North Carolina, 27157
Pfizer Investigational Site
Zanesville, Ohio, 43701
Canada5 sites
Pfizer Investigational Site
Fleurimont, Quebec, J1H 5N4
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2E2
Pfizer Investigational Site
Kingston, Ontario, K7L 5P9
Pfizer Investigational Site
Kitchener, Ontario, N2G 1G3
Pfizer Investigational Site
Windsor, Ontario
About this study
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Blood draw
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of genotype with safety and efficacy measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startSep 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140036
- Sponsor's protocol ID
- CPTAIV-0020-366
- Other IDs
- A5961020
- Status last verified
- Feb 2008
- First submitted
- 29 Aug 2005
- Last updated
- 3 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).
- ClinicalTrials.gov ID
- NCT00140036
- Acronym / sponsor ID
- CPTAIV-0020-366
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Study completion
- Aug 2005
- First posted
- 31 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in studies employing treatment with irinotecan and a signed informed consent.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw | Procedure or surgery | – |
Primary outcome
Correlation of genotype with safety and efficacy measures.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood draw in people with Colorectal Neoplasms, run by Pfizer at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of genotype with safety and efficacy measures.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2008; AzTrials last refreshed its copy on 7 Nov 2026.