Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040729
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2002-07-08
Brief Title:
Genetic Study of Patients Previously Treated With Flavopiridol on Clinical Trial NCI-97-C-0171C
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a persons genetic makeup
PURPOSE Genetic trial to determine whether different forms of the UGT1A1 gene are related to the bodys ability to break down drugs and to the gastrointestinal side effects seen in patients previously treated with flavopiridol
PURPOSE Genetic trial to determine whether different forms of the UGT1A1 gene are related to the bodys ability to break down drugs and to the gastrointestinal side effects seen in patients previously treated with flavopiridol
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0161 | None | None | None |