Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871
Recruitment status was Active, not recruiting
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about how docetaxel is used by the body.
PURPOSE: This research study is looking at DNA in tissue samples from Caucasian and African-American cancer patients who received docetaxel on clinical trial CLB-9871.
Head and Neck Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Genetic: DNA analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: pharmacological study
|Official Title:||A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients|
- Association of an ABBC2 polymorphism (rs12762549) and a SLC01B3 polymorphism (rs11045585) with docetaxel exposure [ Designated as safety issue: No ]
- Grade III/IV leukopenia/neutropenia (induced by docetaxel) and other measures of docetaxel exposure (e.g., AUC) [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
- To determine the genotype of ABCC2 and SLC01B3 (and other genes potentially relevant in the pharmacokinetics and pharmacodynamics of docetaxel in the future) in Caucasian and African-American cancer patients enrolled on clinical trial CLB-9871.
- Explore the relationships between these genotypes and the pharmacokinetic parameters (e.g., AUC, Vdss) of docetaxel.
OUTLINE: An aliquot from each DNA sample collected on clinical trial CLB-9871 is examined for ABCC2 and SLC01B3 genotyping using TaqMan analysis. The genotypes/haplotypes for the candidate genes will be correlated with the pharmacokinetic parameters of docetaxel and docetaxel-related toxicity.
Other genes related to the pharmacokinetics and side effects of docetaxel may be considered for future genotyping. In some cases, panels of drug response SNPs on high-density arrays may be genotyped.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015963
|Study Chair:||Lionel D. Lewis, MD||Norris Cotton Cancer Center|
|Investigator:||Deanna L. Kroetz, PhD||University of California, San Francisco|