Pharmacokinetic Study of Adjuvant Capecitabine After Resection of Pancreatic Adenocarcinoma

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Surgery included proximal pancreatico-duodenectomy

• Complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection)

• Histological confirmation of the primary diagnosis and examination of all resection margins

• At least 4 weeks since surgery, fully recovered from the operation and fit to take part in the trial

• Age ≥ 18 years

• World Health Organisation (WHO) performance status of ≤ 2 (Appendix 1)

• Haemoglobin (Hb) ≥ 9.0 g/dl

• Neutrophils ≥ 1.5 x 109/L

• Platelets (Plts) ≥ 100 x 109/L

• Serum bilirubin ≤ 1.5 x upper normal limit

• Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) ≤ 2.0 x upper limit of normal (ULN)

• Calculated creatinine clearance ≥ 50 ml/min (uncorrected value) or isotope clearance measurement ≥ 50ml/min

• Female patients of child-bearing potential must have a negative serum pregnancy test 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 and documented.

Exclusion Criteria:

• Pregnancy or Lactation

• Evidence of malignant ascites, peritoneal or liver metastasis, spread to other distant abdominal or extra-abdominal organs.

• Concurrent mechanical or malabsorptive disorders precluding affective oral administration of the drug (excluding malabsorption related directly to proximal pancreatic-duodenectomy)

• Patients with pancreatic lymphoma or other histological diagnosis

• Macroscopically remaining tumour (R2 resection)

• Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection.

• Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.

• Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).

• History of confirmed Ischaemic Heart Disease, concurrent congestive heart failure or prior history of class III/ IV cardiac disease (New York Heart Association [NYHA] - refer to Appendix 5)

• Any serious medical or psychological condition precluding adjuvant treatment