A Pharmacokinetic Study of Capecitabine in Patients Undergoing Peri-operative Chemotherapy and a Total Gastrectomy for Adenocarcinoma of the Stomach
- To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a
- To compare the pharmacokinetic profile of capecitabine administered to patients with
gastric cancer pre- and post-gastrectomy and to compare this to historical data of
capecitabine PK values in patients with other cancer types.
- To ensure equivalent capecitabine exposure when compared to PK data from the same
patients prior to gastrectomy.
This is a clinical trial to evaluate the pharmacokinetics (PK) of capecitabine in patients
who have undergone a total gastrectomy. The study also aims to establish the toxicity
profile of capecitabine in these patients, to identify any dose limiting toxicities (DLT),
and to ensure equivalent capecitabine exposure when compared to PK data from the same
patients prior to gastrectomy. Screening tests will consist of demographic details, complete
medical history, physical exam, vital signs, tumour serum markers, haematology and
biochemistry tests. There will also be an ECG, chest X-Ray or CT thorax, CT abdomen and a
serum or urine pregnancy test (for women of childbearing potential). Haematology and
Biochemistry will be repeated prior to each study drug administration. All patients will
receive 6 cycles of oral capecitabine chemotherapy at a dose of 625 mg/m2, administered
twice daily at 12 hourly intervals for 21 consecutive days. Total proposed duration of
therapy is 3 cycles pre-operatively and 3 cycles post-operatively. Capecitabine and its
metabolites (DFCR, DFUR and 5-FU) plasma levels will be measured during the 1st and 4th
cycles in all patients. Treatment should continue for 6 cycles unless there is evidence of
disease progression, or unacceptable toxicity.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone a total gastrectomy.
Samples collected predose and 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, and 24 hours on day 1 of cycles 1 and 4
Duncan Jodrell, DM MSc FRCP
Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge
United Kingdom: Medicines and Healthcare Products Regulatory Agency