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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
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
...and 13 more locations
Progression free survival
The primary objective of the trial is to investigate the outcome of sequential administration of nab-paclitaxel combined with gemcitabine (ABX/GEM, 24 hours apart) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in terms of progression-free survival.
Time frame: From participant randomisation to the point at which disease progression is reported (i.e. 12 months)
Patient Safety
Adverse Events (including Serious Adverse Events), abnormal laboratory test results and performance status
Time frame: 1 year after end of treatment visit
Treatment Efficacy
response to treatment assessed using radiological RECIST criteria
Time frame: 8 weeks
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