Overview

This trial is active, not recruiting.

Conditions bladder cancer, breast cancer, head and neck cancer, lung cancer, unspecified adult solid tumor, protocol specific
Treatment laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date October 2008
End date January 2100
Trial size 69 participants
Trial identifier NCT01015963, CALGB-60805, CDR0000617756, U10CA031946

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Arm
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.
laboratory biomarker analysis
Perform DNA sample analysis

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Incidence of grade III/IV leukopenia/neutropenia (induced by docetaxel)
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

- Registration to CALGB 9871 - Samples present within the CALGB Pathology Coordinating Office that are sufficient to meet study aims

Additional Information

Official title A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.