Pharmacokinetic Study of Adjuvant Capecitabine After Resection of Pancreatic Adenocarcinoma
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||A Pharmacokinetic Study of Adjuvant Capecitabine in Patients Who Have Undergone Proximal Pancreatico-duodenectomy for Resection of Pancreatic Adenocarcinoma|
- To measure plasma levels of Capecitabine and its metabolites (DFCR, DFUR and 5-FU) [ Time Frame: 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 3 ] [ Designated as safety issue: No ]
- To evaluate adverse effects after every course of chemotherapy according to NCI-CTCAE V3. [ Time Frame: 1 year (from patient registration until 28 days after last study drug administration). ] [ Designated as safety issue: No ]
- To identify any dose limiting toxicities of Capecitabine [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone proximal pancreatico-duodenectomy.
- To establish the toxicity profile of capecitabine in these patients and to identify any dose limiting toxicities (DLT).
- To ensure equivalent capecitabine exposure when compared to previous studies using patients who have not undergone such surgery.
This is a clinical trial to evaluate the pharmacokinetics (PK) of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy. 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 previous studies using patients who have not undergone such surgery. 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 (DFCR, DFUR and 5-FU) plasma levels will be measured during the 1st and 3rd cycles in all patients. Treatment should continue for 8 cycles unless there is evidence of disease progression, or unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854477
|Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre|
|Cambridge, United Kingdom, CB2 0QQ|
|Edinburgh Cancer Centre, Western General Hospital|
|Edinburgh, United Kingdom|
|Principal Investigator:||Duncan Jodrell, DM MSc FRCP||Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge|