Investigation of Genetic Determinants of Capecitabine Toxicity

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00977119

Run by

University of Chicago

People needed

240

Starts

2009-11-23

Expected to finish

2021-06-21

Last updated by the study team

2024-07-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• women with breast cancer in whom single agent capecitabine therapy is being considered
• aged 18 years and older

You may not qualify if…

• 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

Where it is running

• University of Alabama - Birmingham — Birmingham, Alabama, United States
• Georgetown University — Washington D.C., 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
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor University — Houston, Texas, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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