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Investigation of Genetic Determinants of Capecitabine Toxicity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00977119
Recruitment Status : Active, not recruiting
First Posted : September 15, 2009
Last Update Posted : April 22, 2019
Translational Breast Cancer Research Consortium
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

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.

Condition or disease Intervention/treatment
Breast Cancer Other: Side-effect questionnaires Other: research blood samples

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Genetic Determinants of Capecitabine Toxicity
Study Start Date : November 2009
Actual Primary Completion Date : May 31, 2015
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Genetic variants of toxicity [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Time to toxicity based on genetics [ Time Frame: 2 years ]
  2. Multiple genetic variants as predictors [ Time Frame: 2 years ]
  3. Genome-wide association (potential) [ Time Frame: 2 years ]
  4. Correlative sample collection [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood (including DNA)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00977119

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United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27708
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 73232
United States, Texas
Baylor University
Houston, Texas, United States, 77030
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
University of Chicago
Translational Breast Cancer Research Consortium
National Institutes of Health (NIH)
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Study Chair: Peter H O'Donnell, MD University of Chicago

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Responsible Party: University of Chicago Identifier: NCT00977119     History of Changes
Other Study ID Numbers: 09-056-B
TBCRC 015 ( Other Identifier: Translational Breast Cancer Reseach Consortium )
First Posted: September 15, 2009    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Keywords provided by University of Chicago:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents