Investigation of Genetic Determinants of Capecitabine Toxicity

April 26, 2023 updated by: University of Chicago

The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).

Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama - Birmingham
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Evanston, Illinois, United States, 60201
        • NorthShore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina - Chapel Hill
      • Durham, North Carolina, United States, 27708
        • Duke University
    • Tennessee
      • Nashville, Tennessee, United States, 73232
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • M.D. Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.

Description

Inclusion Criteria:

  • women with breast cancer in whom single agent capecitabine therapy is being considered
  • aged 18 years and older

Exclusion Criteria:

  • patients who have previously received capecitabine are excluded
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capecitabine
Women with breast cancer receiving capecitabine as treatment for their breast cancer.
Other: Side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
Other: research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Genetic variants of toxicity
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to toxicity based on genetics
Time Frame: 2 years
2 years
Multiple genetic variants as predictors
Time Frame: 2 years
2 years
Genome-wide association (potential)
Time Frame: 2 years
2 years
Correlative sample collection
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institutes of Health (NIH)
Translational Breast Cancer Research Consortium

Investigators

  • Study Chair: Peter H O'Donnell, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

May 15, 2024

Study Completion (Anticipated)

May 15, 2024

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimate)

September 15, 2009

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-056-B
  • TBCRC 015 (Other Identifier: Translational Breast Cancer Reseach Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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