Capecitabine PK Gastric (CAP002)
Research type
Research Study
Full title
A pharmacokinetic study of capecitabine in patients undergoing peri-operative chemotherapy and a total gastrectomy for adenocarcinoma of the stomach
IRAS ID
19433
Contact name
Duncan Jodrell
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Eudract number
2009-009908-39
Clinicaltrials.gov Identifier
Research summary
This is a clinical trial to evaluate the pharmacokinetics (PK) of adjuvant capecitabine in patients who have undergone a total gastrectomy. The study will compare the pharmacokinetic profile of capecitabine administered to patients with gastric cancer pre- and post-gastrectomy (using patients as their own controls) and also compare the data accrued with historical data for capecitabine PK. The aim is to ensure equivalent capecitabine exposure following total gastrectomy. Screening tests will consist of demographic details, complete medical history, physical exam, vital signs, haematology and biochemistry tests. ECG, tumour measurement (CT abdomen, Chest X-ray or CT Chest) and a serum or urine pregnancy test (for women of childbearing potential) will also be performed. Haematology and biochemistry will be repeated prior to each study drug administration.All patients will receive ECX chemotherapy which includes epirubicin 50mg/m2 (iv bolus) on day 1, cisplatin 60mg/m2 (iv infusion) on day 1 and oral capecitabine chemotherapy at a dose of 625mg/m2 administered twice daily at 12 hourly intervals for 21 consecutive days out of a 21 day cycle.The concentration of capecitabine and its metabolites (DFCR, DFUR, 5-FU and FBAL) in plasma will be measured during the 1st and 4th cycles in all patients, using an established analytical method. An optional pharmacogenetic sample will be collected.Treatment will continue for 3 cycles pre-operatively and 3 cycles post-operatively unless there is evidence of disease progression on chemotherapy, unacceptable toxicity or treatment is discontinued at the patient??s request. Following completion or discontinuation of chemotherapy, follow-up will continue to be undertaken by their specialist (oncological and surgical) teams.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
09/H0904/38
Date of REC Opinion
8 Jul 2009
REC opinion
Favourable Opinion