Association of capecitabine pharmacokinetics and toxicity with aging
Research type
Research Study
Full title
A prospective evaluation of capecitabine and metabolite pharmacokinetics in elderly breast and colorectal cancer patients and their association with toxicity and molecular markers of enzyme activity and aging
IRAS ID
160670
Contact name
Nicola Cresti
Contact email
Sponsor organisation
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eudract number
2015-001610-10
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
Although great progress has been made in the treatment of breast and colorectal cancer in recent years, we still need to develop better treatments and to tailor existing treatments more effectively to individuals of all ages who have cancer. At the moment, we select chemotherapy drugs for patients based on the results of clinical trials of large numbers of patients. However, the elderly (usually considered to be those patients greater than age 65) are under-represented in cancer drug trials, despite their being the age group most likely to be diagnosed with cancer. The way the body handles a drug often changes with increasing age, and we wish to assess whether or not this is true of capecitabine. However, chronological age (age in years) is not necessarily the best predictor of response to therapy or side effects of cancer treatment, since the elderly as a group differ widely in health and fitness levels. Therefore we wish to better understand the body’s handling of capecitabine with increasing age in breast and colorectal cancer patients and to evaluate alternative ways to predict response to therapy and risk of side effects.
The purpose of this study is to see if we can identify any differences between the way capecitabine is handled by the body between older (>65 years old) and younger patients. In addition, we wish to evaluate several naturally-occurring substances in the blood (called biomarkers and enzymes) to see if they are associated with age in breast and colorectal cancer patients and if they are associated with how the body handles capecitabine, response to treatment, and side effects of treatment.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0025
Date of REC Opinion
25 Feb 2016
REC opinion
Favourable Opinion