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
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|
|Unspecified Adult Solid Tumor, Protocol Specific||Genetic: mutation analysis|
- 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 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 :||March 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040729
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||William D. Figg, PharmD||National Cancer Institute (NCI)|