Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871
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|ClinicalTrials.gov Identifier: NCT01015963|
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment|
|Bladder Cancer Breast Cancer Head and Neck Cancer Lung Cancer Unspecified Adult Solid Tumor, Protocol Specific||Other: laboratory biomarker analysis|
I. To determine the genotype of ATP-binding cassette, sub-family C (CFTR/MRP), member 2 (ABCC2) and solute carrier organic anion transporter family, member 1B3 (SLCO1B3) (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.
II. Explore the relationships between these genotypes and docetaxel pharmacokinetic parameters (e.g., area under curve [AUC], steady-state volume of distribution [Vdss]).
Blood samples collected on clinical trial CLB-9871 are examined via ABCC2 and SLC01B3 genotyping using TaqMan analysis. Other genes related to the pharmacokinetics and side effects of docetaxel may be considered for future genotyping. In some cases, panels of drug response single nucleotide polymorphisms (SNPs) on high-density arrays may be genotyped.
|Study Type :||Observational|
|Actual Enrollment :||69 participants|
|Official Title:||A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 1, 2013|
Ancillary-correlative (DNA sample analysis)
Blood samples collected on clinical trial CLB-9871 are examined via ABCC2 and SLC01B3 genotyping using TaqMan analysis. 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.
Other: laboratory biomarker analysis
Perform DNA sample analysis
- Incidence of ABBC2 polymorphism (rs12762549) and a SLC01B3 polymorphism (rs11045585) with docetaxel exposure [ Time Frame: Up to 2 years ]
- Incidence of SLC01B3 polymorphism (rs11045585) [ Time Frame: Up to 2 years ]
- Incidence of grade III/IV leukopenia/neutropenia (induced by docetaxel) [ Time Frame: Up to 2 years ]
Biospecimen Retention: Samples With DNA
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): NCT01015963
|Study Chair:||Lionel D. Lewis, MD||Norris Cotton Cancer Center|