NCT00854477

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2009

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

February 27, 2009

Last Update Submit

February 15, 2013

Conditions

Pancreatic Adenocarcinoma

Keywords

capecitabinePost whipplespancreatico-duodenectomypancreatic adenocarcinomapharmacokinetic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Interventions

capecitabineDRUG

film-coated tablet 1250 mg/m2 twice daily for 14 days every 3 weeks. Number of cycles: 8 cycles unless there is evidence of disease progression, or unacceptable toxicity

Also known as: Xeloda

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cambridge University Hospitals NHS Foundation Trust, University of Cambridge Oncology Centre

Cambridge, CB2 0QQ, United Kingdom

Location

Edinburgh Cancer Centre, Western General Hospital

Edinburgh, United Kingdom

Location

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Duncan Jodrell, DM MSc FRCP

    Cambridge University Hospitals, NHS Foundation Trust, University of Cambridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Duncan Jodrell

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 3, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

GB(2)