Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871
NCT ID: NCT01015963
Last Updated: 2017-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
69 participants
OBSERVATIONAL
2008-10-31
2013-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of DNA in Blood Samples From Patients With Neuroblastoma
NCT00898391
Detection of Tumor DNA in Blood Samples From Cancer Patients
NCT02288754
Collecting and Storing Blood Samples From Patients With Cancer
NCT00900120
DNA in Predicting Response After Systemic Therapy in Women With Metastatic Breast Cancer
NCT00899548
Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer to Study Drug Resistance
NCT00026663
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
laboratory biomarker analysis
Perform DNA sample analysis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laboratory biomarker analysis
Perform DNA sample analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Samples present within the CALGB Pathology Coordinating Office that are sufficient to meet study aims
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lionel D. Lewis, MD
Role: STUDY_CHAIR
Norris Cotton Cancer Center
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CALGB-60805
Identifier Type: -
Identifier Source: secondary_id
CDR0000617756
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-60805
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.