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


N/A
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer, Breast Cancer, Head and Neck Cancer, Lung Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Association of an ABBC2 polymorphism (rs12762549) and a SLC01B3 polymorphism (rs11045585) with docetaxel exposure

Safety Issue:

No

Principal Investigator

Lionel D. Lewis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000617756

NCT ID:

NCT01015963

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Bladder Cancer
  • Breast Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • stage III adenoid cystic carcinoma of the oral cavity
  • stage III mucoepidermoid carcinoma of the oral cavity
  • stage III verrucous carcinoma of the oral cavity
  • stage IV adenoid cystic carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • recurrent lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III lymphoepithelioma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage III inverted papilloma of the paranasal sinus and nasal cavity
  • stage III midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent salivary gland cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • unspecified adult solid tumor, protocol specific
  • tongue cancer
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms

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