Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871
Official Title
A Study of the Docetaxel Pharmacodynamics and Polymorphisms in ABCC2 and SLC01B3 in Caucasian and African-American Cancer Patients
Acronym
Not provided
Organization
Alliance for Clinical Trials in OncologyOTHER
Status Module
Record Verification Date
Jul 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2008
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 1, 2013Actual
First Submitted Date
Nov 17, 2009
First Submission Date that Met QC Criteria
Nov 17, 2009
First Posted Date
Nov 18, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 11, 2017
Last Update Posted Date
Jul 13, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Alliance for Clinical Trials in OncologyOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Bladder Cancer
Breast Cancer
Head and Neck Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
Retention
Enrollment
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ancillary-correlative (DNA sample 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.
Other: laboratory biomarker analysis
Interventions
Name
Type
Description
Arm Group Labels
Other Names
laboratory biomarker analysis
Other
Perform DNA sample analysis
Ancillary-correlative (DNA sample analysis)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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 Outcomes
Measure
Description
Time Frame
Incidence of grade III/IV leukopenia/neutropenia (induced by docetaxel)
Up to 2 years
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Registration to CALGB 9871
Samples present within the CALGB Pathology Coordinating Office that are sufficient to meet study aims
Lewis LD, Miller AA, Owzar K, Bies RR, Markova S, Jiang C, Kroetz DL, Egorin MJ, McLeod HL, Ratain MJ; Alliance for Clinical Trials in Oncology. The relationship of polymorphisms in ABCC2 and SLCO1B3 with docetaxel pharmacokinetics and neutropenia: CALGB 60805 (Alliance). Pharmacogenet Genomics. 2013 Jan;23(1):29-33. doi: 10.1097/FPC.0b013e32835b16d8.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
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
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Case-Only
Time Perspective
Retrospective
Masking Info
No data available
No data is available for this block.
Samples With DNA
Description
Blood
ID
Term
D001749
Urinary Bladder Neoplasms
D001943
Breast Neoplasms
D006258
Head and Neck Neoplasms
D008175
Lung Neoplasms
D055752
Small Cell Lung Carcinoma
D002289
Carcinoma, Non-Small-Cell Lung
D000077195
Squamous Cell Carcinoma of Head and Neck
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
D014062
Tongue Neoplasms
Ancestor Terms
ID
Term
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D009369
Neoplasms
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications