Status:
COMPLETED
Pharmacokinetic Study of Adjuvant Capecitabine After Resection of Pancreatic Adenocarcinoma
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of adjuvant capecitabine in patients who have undergone proximal pancreatico-duodenectomy.
Detailed Description
Primary Objective: * To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone proximal pancreatico-duodenectomy. Secondary objectives: * To establish the toxicity profi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00854477
Start Date
November 1 2009
End Date
August 1 2012
Last Update
February 18 2013
Active Locations (2)
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1
Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre
Cambridge, United Kingdom, CB2 0QQ
2
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, United Kingdom