For patients who have undergone proximal pancreatico-duodenectomy for resection of pancreatic adenocarcinoma
Conditions
Interventions
Trade Name: Capecitabine
Product Name: Capecitabine
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabine
Concentrat
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection). • Surgery must have included a proximal pancreatico-duodenectomy. • Histological confirmation of the primary diagnosis and examination of all resection margins • At least 4 weeks since surgery, fully recovered from the operation • Age = 18 years. • World Health Organisation (WHO) performance status of = 2 • Haematological and biochemical indices (These measurements must be performed within one week prior to the patient being registered on the study.) - Haemoglobin (Hb) = 9.0 g/dL (Patients may be transfused to this level, however, HB must be above 9.0 before registration) - Neutrophils = 1.5 x 10^9/L - Platelets (Plts) = 100 x 10^9/L - Serum bilirubin = 1.5 x upper normal limit (ULN) - Alanine amino-transferase (ALT) and / or aspartate amino-transferase (AST) = 2.5 x upper limit of normal (ULN). (If both are measured, both must be = 2.5 x ULN) - Calculated creatinine clearance = 50 mL/min (uncorrected value) or isotope clearance measurement = 50 mL/min • Female patients of child-bearing potential must have a negative serum or urine pregnancy test within two weeks prior to enrolment and agree to use appropriate medically approved contraception for four weeks prior to entering the trial, during the trial, and for six months afterwards. • Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards. • Written, informed consent provided. • Ability of the patient to co-operate with treatment and follow up must be ensured. • Patients receiving oral anti-coagulation prior to entry into the study, must be converted to low molecular weight heparin in light of the interaction between capecitabine and warfarin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with pancreatic lymphoma or other histological diagnosis • Macroscopically remaining tumour (R2 resection) • Evidence of malignant ascites, peritoneal or liver metastasis, or spread to other distant abdominal or extra-abdominal organs. • History of confirmed Ischaemic Heart Disease, concurrent congestive heart failure or prior history of class III / IV cardiac disease • Concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding malabsorption related directly to proximal pancreatic-duodenectomy) • Pregnancy or lactation • Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). • Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection. • Any other serious medical or psychological condition precluding adjuvant treatment • Patients with any other condition which in the Investigator’s opinion would not make the patient a good candidate for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone proximal pancreatico-duodenectomy.; Secondary Objective: 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. ;Primary end point(s): This is a PK sampling study, therefore there are no specific endpoints | — |
Countries
United Kingdom
Outcome results
None listed