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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01015963
Other study ID # CALGB-60805
Secondary ID CALGB-60805CDR00
Status Completed
Phase N/A
First received November 17, 2009
Last updated July 11, 2017
Start date October 2008
Est. completion date January 1, 2013

Study information

Verified date July 2017
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date January 1, 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Registration to CALGB 9871

- Samples present within the CALGB Pathology Coordinating Office that are sufficient to meet study aims

Study Design


Intervention

Other:
laboratory biomarker analysis
Perform DNA sample analysis

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

References & Publications (1)

Lewis LD, Miller AA, Owzar K, Bies RR, Markova S, Jiang C, Kroetz DL, Egorin MJ, McLeod HL, Ratain MJ; Alliance for Clinical Trials in Oncology. The relationship of polymorphisms in ABCC2 and SLCO1B3 with docetaxel pharmacokinetics and neutropenia: CALGB — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ABBC2 polymorphism (rs12762549) and a SLC01B3 polymorphism (rs11045585) with docetaxel exposure Up to 2 years
Primary Incidence of SLC01B3 polymorphism (rs11045585) Up to 2 years
Secondary Incidence of grade III/IV leukopenia/neutropenia (induced by docetaxel) Up to 2 years
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