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Title

A prospective, phase II, double blinded, multicentre, randomised clinical trial comparing combination gemcitabine and Vandetanib therapy with gemcitabine therapy alone in locally advanced or metastatic pancreatic carcinoma


Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
II Treatment FollowUp >= 18 yrs University of Liverpool and RLBUHT EUDRACT No: 2010-021951-26
ISRCTN No: 74555382

Purpose

Pancreatic cancer is a significant health problem for which there is a huge unmet therapeutic need and which carries a uniquely poor prognosis, with incidence rates and mortality rates being almost equivalent. In the small number of patients who have resectable disease, the five year survival rates are only around 10%. The outcome for patients treated with radiotherapy for locally advanced disease and chemotherapy for metastatic disease is dismal: the most active chemotherapy regimens seldom achieve response rates of over 20%.

Gemcitabine therapy alone is the regulatory standard of care. However, there has been significant growth in the knowledge of the molecular characteristics of the disease and improvements in treatment outcome will only be achieved with the integration of novel therapy targeted to these abnormalities. There is a strong clinical evidence-based rationale for building upon and further investigating the impact of dual epidermal growth factor (EGF) receptor and vascular endothelial growth factor (VEGF) receptor blockade in pancreatic cancer.

Vandetanib is a potent inhibitor of the tyrosine kinase activity of kinase insert domain-containing receptor, an endothelial cell receptor for VEGF and also possesses activity against EGF receptors.

The main aim of the study is to assess if the combination of the two treatments increases the survival time compared to just gemcitabine therapy alone.


Trial Lead Organisations

  • The University of Liverpool
  • Royal Liverpool and Broadgreen University Hospitals Trust
  • Chief Investigator: Dr Gary Middleton, Royal Surrey County Hospital
  • Astra Zeneca


Official Title

A prospective, phase II, double blinded, multicentre, randomised clinical trial comparing combination gemcitabine and Vandetanib therapy with gemcitabine therapy alone in locally advanced or metastatic pancreatic carcinoma


Trial Start Date

10/10/2011


References


Trial Coordinator

Zaira Yunus


Trial Coordinator Email Address

z.yunus@liv.ac.uk


Trial Coordinator Contact No

0151 794 8935


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"The experience and treatment I received at the Royal Liverpool Hospital was so fantastic that I had to tell the people involved with my treatment how marvelous they were, so please would you pass on my thanks and gratitude to Professor Neoptolemos and his team of surgeons, the wonderful doctors and nursing staff" - Anon (Participant in ESPAC-3(v2) trial)

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