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
Recruitment status was Active, not recruiting
Sponsor:
Cancer and Leukemia Group B
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
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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:
MedlinePlus related topics:
Benign Tumors
Bladder Cancer
Breast Cancer
Cancer
Head and Neck Cancer
Lung Cancer
U.S. FDA Resources
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) |
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 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 June 18, 2013