Investigation of Genetic Determinants of Capecitabine Toxicity
NCT ID: NCT00977119
Last Updated: 2024-07-31
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
240 participants
OBSERVATIONAL
2009-11-23
2021-06-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predicting Response to Capecitabine in Women With Metastatic Breast Cancer
NCT00953537
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism
NCT00960544
Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine
NCT00156312
Companion Pharmacogenetic Study to UMCC 9900/9901
NCT00146029
Phase II Study of Capecitabine and Weekly Docetaxel Followed by Capecitabine Maintenance for Patients With Metastatic Breast Carcinoma
NCT00225056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Capecitabine
Women with breast cancer receiving capecitabine as treatment for their breast cancer.
Side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* aged 18 years and older
Exclusion Criteria
* patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
* serum albumin less than 3.0 g/dL within the last 30 days
* creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min \[/body surface area (BSA)\] (within the last 30 days)
* inability to understand and give informed consent to participate
* patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus
* patients with prior or concurrent pelvic irradiation
* patients who use an ostomy for fecal excretion
* there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Translational Breast Cancer Research Consortium
OTHER
National Institutes of Health (NIH)
NIH
University of Chicago
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.
Peter H O'Donnell, MD
Role: STUDY_CHAIR
University of Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama - Birmingham
Birmingham, Alabama, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Chicago
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Johns Hopkins
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University
Houston, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TBCRC 015
Identifier Type: OTHER
Identifier Source: secondary_id
09-056-B
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.