Investigation of Genetic Determinants of Capecitabine Toxicity

University of Chicago13 sites in 1 country240 target enrollmentNovember 23, 2009

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of Chicago
Enrollment: 240
Locations: 13
Primary Endpoint: Genetic variants of toxicity
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 23, 2009

End Date

June 21, 2021

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

University of Chicago

Responsible Party

Sponsor

Eligibility Criteria

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