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Randomised Phase II Trial to Investigate Two Different Schedules of Nab-paclitaxel (Abraxane) Combined With Gemcitabine as First Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma
Metastatic pancreatic cancer is difficult to treat. Until recently, most patients would be offered treatment with a chemotherapy drug called gemcitabine. However, a large international trial showed that combining gemcitabine with a drug called nab-paclitaxel (or abraxane) was more effective compared with gemcitabine alone. The purpose of this study is to compare two different ways of combining gemcitabine with abraxane. Conventionally, both drugs are given on the same day via a drip into a vein in the arm but research suggests that giving abraxane 24 hours in advance of gemcitabine could possibly be more beneficial. In this study, blood and tumour samples will be collected and analysed to try to confirm what has been seen in the laboratory studies. In addition, the investigators wish to find out whether certain tumour characteristics (called biomarkers) can be used to predict for response to chemotherapy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Peterborough City Hospital
Peterborough, Cambridgeshire, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Colchester Hospital
Colchester, United Kingdom
University Hospitals Coventry & Warwickshire
Coventry, United Kingdom
Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
Start Date
January 1, 2014
Primary Completion Date
June 1, 2016
Completion Date
June 1, 2016
Last Updated
July 16, 2019
146
ACTUAL participants
Abraxane (nab-paclitaxel)
DRUG
Gemcitabine
DRUG
Lead Sponsor
CCTU- Cancer Theme
Collaborators
NCT01053013
NCT01715142
Data Source & Attribution
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