Trials / Completed
CompletedNCT01015963
Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871
A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 69 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This research trial studies deoxyribonucleic acid (DNA) in blood samples from Caucasian and African-American cancer patients who received docetaxel on clinical trial CLB-9871. Studying samples of blood 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.
Detailed description
PRIMARY OBJECTIVES: 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 \[Vdss\]). OUTLINE: 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.
Conditions
- Bladder Cancer
- Breast Cancer
- Head and Neck Cancer
- Lung Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | laboratory biomarker analysis | Perform DNA sample analysis |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2009-11-18
- Last updated
- 2017-07-13
Source: ClinicalTrials.gov record NCT01015963. Inclusion in this directory is not an endorsement.