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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00040729 |
Purpose
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 | Intervention |
|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Genetic: mutation analysis |
| 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 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| 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) |
More Information
| Study ID Numbers: | CDR0000069394, NCI-02-C-0161 |
| Study First Received: | July 8, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00040729 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Flavopiridol Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Enzyme Inhibitors Growth Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
