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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


N/A
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

William D. Figg, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000069394

NCT ID:

NCT00040729

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182