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



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

For Condition: unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 the gastrointestinal side effects seen in patients previously treated with flavopiridol.
Details: OBJECTIVES: I. 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. PROTOCOL 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Cancer patients previously treated with flavopiridol on protocol NCI-97-C-0171C --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
WilliamFigg,  Study Chair,  National Cancer Institute (NCI)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda,  Maryland,  20892-1182
United States
 


Additional Information:
Study ID Numbers:
  CDR0000069394;  NCI-02-C-0161
Study Start Date: March 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040729

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

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