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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 29, 2005
Last updated: February 28, 2008
Last verified: February 2008
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).

Resource links provided by NLM:

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00140036

  Show 34 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

No publications provided Identifier: NCT00140036     History of Changes
Other Study ID Numbers: CPTAIV-0020-366  A5961020 
Study First Received: August 29, 2005
Last Updated: February 28, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 11, 2016