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Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00040729
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

RATIONALE: Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup.

PURPOSE: Genetic trial to determine whether different forms of the UGT1A1 gene are related to the body's ability to break down drugs and to the gastrointestinal side effects seen in patients previously treated with flavopiridol.

Condition or Disease Intervention/Treatment Phase
  • Genetic: mutation analysis

Detailed Description

OBJECTIVES:
  • Determine the relationship between UGT1A1 genotypes and drug pharmacokinetics and occurrence of gastrointestinal toxicity in cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C.

OUTLINE: Genomic DNA from pre-existing samples of serum or plasma from each patient is analyzed for UGT1A1 gene by polymerase chain reaction and DNA sequencing. Results are then analyzed for a possible association between UGT1A1 genotypic variation and susceptibility to flavopiridol.

Patients do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Design

Study Type:
Observational
Official Title:
Retrospective Analysis Of Promoter Polymorphism Of UGT1A1 Gene In Cancer Patients Enrolled On Clinical Trials With Flavopiridol At National Cancer Institute To Assess The Pharmacokinetics And Pharmacodynamics Of Flavopiridol
Study Start Date :
Mar 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C
    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Not specified
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:
    • Not specified
    Renal:
    • Not specified
    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • See Disease Characteristics
    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • Not specified
    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland United States 20892-1182

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: William D. Figg, PharmD, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00040729
    Other Study ID Numbers:
    • CDR0000069394
    • NCI-02-C-0161
    First Posted:
    Jun 26, 2003
    Last Update Posted:
    Apr 28, 2015
    Last Verified:
    May 1, 2003
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific

    Study Results

    No Results Posted as of Apr 28, 2015