Status:
COMPLETED
Investigation of Genetic Determinants of Capecitabine Toxicity
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Translational Breast Cancer Research Consortium
National Institutes of Health (NIH)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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). Additional...
Eligibility Criteria
Inclusion
- women with breast cancer in whom single agent capecitabine therapy is being considered
- aged 18 years and older
Exclusion
- 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
Key Trial Info
Start Date :
November 23 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00977119
Start Date
November 23 2009
End Date
June 21 2021
Last Update
July 31 2024
Active Locations (13)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Georgetown University
Washington D.C., District of Columbia, United States, 20007
3
University of Chicago
Chicago, Illinois, United States, 60637
4
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201