Capecitabine PK Post Whipples (CAP001)
Research type
Research Study
Full title
A Pharmacokinetic Study of Adjuvant Capecitabine in Patients who have undergone Proximal Pancreatico-duodenectomy for Resection of Pancreatic Adenocarcinoma
IRAS ID
6135
Contact name
Duncan Jodrell
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2008-008476-14
Clinicaltrials.gov Identifier
Research summary
This is a clinical trial to evaluate the pharmacokinetics (PK) of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy. Capecitabine is being assessed in combination with gemcitabine in the ESPAC-4, Phase III trial in patients undergoing resection of their pancreatic cancer. The study aims to to ensure equivalent capecitabine exposure when compared to previous studies using patients who have not undergone such surgery. A secondary aim is to establish the toxicity profile of capecitabine in these patients and to identify any dose limiting toxicities (DLT) 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, faecal elastase measurement and a serum or urine pregnancy test (for women of childbearing potential). Haematology and Biochemistry (including CA19.9) will be repeated prior to each study drug administration. All patients will receive 8 cycles of oral capecitabine chemotherapy at a dose of 1250 mg/m2, administered twice daily at 12 hourly intervals for 14 consecutive days out of a 21 day cycle. Total proposed duration of therapy is 24 weeks, assuming patients commence all cycles without delay. Capecitabine and its metabolites (including DFCR, DFUR and 5-FU) plasma levels will be measured during the 1st and 3rd cycles in all patients. An optional pharmacogenetic blood sample will be collected. Treatment should continue for 8 cycles unless there is evidence of disease progression, or unacceptable toxicity.
REC name
London - Central Research Ethics Committee
REC reference
09/H0718/27
Date of REC Opinion
7 Aug 2009
REC opinion
Further Information Favourable Opinion