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

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ClinicalTrials.gov Identifier: NCT00040729
Recruitment Status : Completed
First Posted : June 26, 2003
Last Update Posted : April 28, 2015
Sponsor:
Information provided by:
National Cancer Institute (NCI)

July 8, 2002
June 26, 2003
April 28, 2015
March 2002
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Complete list of historical versions of study NCT00040729 on ClinicalTrials.gov Archive Site
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Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
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

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.

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.

Observational
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Unspecified Adult Solid Tumor, Protocol Specific
Genetic: mutation analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00040729
CDR0000069394
NCI-02-C-0161
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National Cancer Institute (NCI)
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Study Chair: William D. Figg, PharmD National Cancer Institute (NCI)
National Cancer Institute (NCI)
May 2003