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