Pharmacokinetic study of adjuvant capecitabine after resection of pancreatic adenocarcinoma
- Conditions
- Pancreatic adenocarcinomaCancerMalignant neoplasm of pancreas
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1. Complete macroscopic resection for pathologically proven ductal adenocarcinoma (or poorly differentiated/undifferentiated carcinoma) of the pancreas (R0 or R1 resection)
2. Surgery must have included a proximal pancreatico-duodenectomy
3. Histological confirmation of the primary diagnosis and examination of all resection margins
4. At least 4 weeks since surgery, fully recovered from the operation and all surgical wounds fully healed
5. Aged greater than or equal to 18 years, either sex
6. World Health Organisation (WHO) performance status of less than or equal to 2
7. Haematological and biochemical indices (these measurements must be performed within one week prior to the patient being registered on the study):
7.1. Haemoglobin (Hb) greater than or equal to 9.0 g/dl (patients may be transfused to this level, however, Hb must be above 9.0 g/dl before registration)
7.2. Neutrophils greater than or equal to 1.5 x 10^9/l
7.3. Platelets (Plts) greater than or equal to 100 x 10^9/l
7.4. Serum bilirubin less than or equal to 1.5 x upper normal limit (ULN)
7.5. Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) less than or equal to 2.0 x ULN (if both are measured, both must be less than or equal to 2.0 x ULN)
7.6. Calculated creatinine clearance greater than or equal to 50 ml/min (uncorrected value) or isotope clearance measurement greater than or equal to 50 ml/min
8. 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
9. Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards
10. Written, informed consent provided
11. Ability of the patient to co-operate with treatment and follow up must be ensured
12. 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
1. Patients with pancreatic lymphoma or other histological diagnosis
2. Macroscopically remaining tumour (R2 resection)
3. Evidence of malignant ascites, peritoneal or liver metastasis, or spread to other distant abdominal or extra-abdominal organs
4. History of confirmed ischaemic heart disease, concurrent congestive heart failure or prior history of class III/IV cardiac disease
5. Concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding malabsorption related directly to proximal pancreatic-duodenectomy)
6. Pregnancy or lactation
7. Patients known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
8. Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection
9. Any other serious medical or psychological condition precluding adjuvant treatment
10. Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method