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Investigation of Genetic Determinants of Capecitabine Toxicity

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Investigation of Genetic Determinants of Capecitabine Toxicity

Inclusion Criteria:

- women with breast cancer in whom single agent capecitabine therapy is being

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Genetic variants of toxicity

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Peter H O'Donnell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

November 2009

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • breast cancer
  • capecitabine
  • Breast Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624
Mayo Clinic Rochester, Minnesota  55905
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Duke University Durham, North Carolina  27710
Baylor University Waco, Texas  
Georgetown University Washington, District of Columbia  20007-2197
M.D. Anderson Cancer Center Houston, Texas  77030
University of Chicago Chicago, Illinois  60637
Johns Hopkins Baltimore, Maryland  21231
University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599
NorthShore University HealthSystem Evanston, Illinois  
University of Alabama - Birmingham Birmingham, Alabama  35294