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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01015963
First received: November 17, 2009
Last updated: February 24, 2011
Last verified: November 2009
  Purpose

RATIONALE: Studying samples of tissue 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.

PURPOSE: This research study is looking at DNA in tissue samples from Caucasian and African-American cancer patients who received docetaxel on clinical trial CLB-9871.


Condition Intervention
Bladder Cancer
Breast Cancer
Head and Neck Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: docetaxel
Genetic: DNA analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: pharmacological study

Study Type: Observational
Official Title: A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Association of an ABBC2 polymorphism (rs12762549) and a SLC01B3 polymorphism (rs11045585) with docetaxel exposure [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade III/IV leukopenia/neutropenia (induced by docetaxel) and other measures of docetaxel exposure (e.g., AUC) [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: February 2009
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine the genotype of ABCC2 and SLC01B3 (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.
  • Explore the relationships between these genotypes and the pharmacokinetic parameters (e.g., AUC, Vdss) of docetaxel.

OUTLINE: An aliquot from each DNA sample collected on clinical trial CLB-9871 is examined for ABCC2 and SLC01B3 genotyping using TaqMan analysis. The genotypes/haplotypes for the candidate genes will be correlated with the pharmacokinetic parameters of docetaxel and docetaxel-related toxicity.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven unresectable solid tumor (e.g., lung, breast, head and neck, or bladder)
  • Enrolled on clinical trial CLB-9871
  • Tissue samples present within the CALGB Pathology Coordinating Office that are sufficient to meet study objectives

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015963

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
Investigator: Deanna L. Kroetz, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01015963     History of Changes
Other Study ID Numbers: CDR0000617756, CALGB-60805
Study First Received: November 17, 2009
Last Updated: February 24, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
stage IV bladder cancer
recurrent bladder cancer
stage III bladder cancer
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
pulmonary carcinoid tumor
recurrent basal cell carcinoma of the lip
recurrent squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Breast Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014