Association of Capecitabine Pharmacokinetics and Toxicity With Aging
Status:
Unknown status
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
This is a multi-centre prospective non-interventional study designed to evaluate the effects
of patient age on the pharmacokinetics of capecitabine and its metabolites 5'DFCR, 5'DFUR,
and 5-FU. In addition, the study will assess the correlation between the pharmacokinetic
parameters calculated and cytidine deaminase, biomarkers of aging, clinical frailty,
treatment outcome, and toxicity. To be enrolled, patients must have breast or colorectal
cancer and be eligible to receive capecitabine monotherapy in accordance with its approved
clinical usage in the UK. Treatment will be administered according to NICE guidelines as well
as the clinical judgement of the prescribing physician. One hundred patients (50 breast
cancer patients, 50 colorectal cancer patients) who are about to start treatment with
capecitabine monotherapy will be recruited to the study and undergo study procedures within
the first week of treatment.