Investigation of Genetic Determinants of Capecitabine Toxicity
- Conditions
- Breast Cancer
- Registration Number
- NCT00977119
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- women with breast cancer in whom single agent capecitabine therapy is being considered
- aged 18 years and older
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genetic variants of toxicity 2 years
- Secondary Outcome Measures
Name Time Method Multiple genetic variants as predictors 2 years Genome-wide association (potential) 2 years Time to toxicity based on genetics 2 years Correlative sample collection 2 years
Trial Locations
- Locations (13)
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Scroll for more (3 remaining)University of Alabama - Birmingham🇺🇸Birmingham, Alabama, United States