Pharmacokinetic Study Of Adjuvant Capecitabine After Resection Of Pancreatic Adenocarcinoma

Study Overview

Pharmacokinetic Study of Adjuvant Capecitabine After Resection of Pancreatic Adenocarcinoma

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

Primary Objective: * To establish the pharmacokinetics (PK) of capecitabine in patients who have undergone proximal pancreatico-duodenectomy. Secondary objectives: * 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.

Pancreatic Adenocarcinoma

DRUG: capecitabine

CAP001
PDDG/CAP001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-02-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-02-15
First Submitted that Met QC Criteria 2009-02-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-02-18
First Posted (ESTIMATED) 2009-03-03	Results First Posted N/A	Last Verified 2013-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Basic Science

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
To measure plasma levels of Capecitabine and its metabolites (DFCR, DFUR and 5-FU)		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

Secondary Outcome Measures	Measure Description	Time Frame
To evaluate adverse effects after every course of chemotherapy according to NCI-CTCAE V3.		1 year (from patient registration until 28 days after last study drug administration).
To identify any dose limiting toxicities of Capecitabine		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Duncan Jodrell, DM MSc FRCP, Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record