Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871

Breast Cancer Clinical Trial

Official title:

A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients

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
• 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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Breast Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lung Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Urinary Bladder Neoplasms

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