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

Completed

• Conditions: Bladder Cancer; Breast Cancer; Head and Neck Cancer; Lung Cancer; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01015963
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-11-17
• Study First Submitted QC: 2009-11-17
• Study First Posted: 2009-11-18
• Primary Completion: 2013-01
• Study Completion: 2013-01-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-correlative (DNA sample analysis)	laboratory biomarker 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.

Primary Outcome Measures

Name	Time	Method
Incidence of ABBC2 polymorphism (rs12762549) and a SLC01B3 polymorphism (rs11045585) with docetaxel exposure	Up to 2 years
Incidence of SLC01B3 polymorphism (rs11045585)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Incidence of grade III/IV leukopenia/neutropenia (induced by docetaxel)	Up to 2 years