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Investigation of Genetic Determinants of Capecitabine Toxicity


N/A
18 Years
N/A
Open (Enrolling)
Female
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
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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Genetic variants of toxicity

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Peter H O'Donnell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Institutional Review Board

Study ID:

09-056-B

NCT ID:

NCT00977119

Start Date:

November 2009

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • breast cancer
  • capecitabine
  • Breast Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Mayo ClinicRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Duke UniversityDurham, North Carolina  27710
Baylor UniversityWaco, Texas  
Georgetown UniversityWashington, District of Columbia  20007-2197
M.D. Anderson Cancer CenterHouston, Texas  77030
University of ChicagoChicago, Illinois  60637
Johns HopkinsBaltimore, Maryland  21231
University of North Carolina - Chapel HillChapel Hill, North Carolina  27599
NorthShore University HealthSystemEvanston, Illinois  
University of Alabama - BirminghamBirmingham, Alabama  35294