A randomised phase II study evaluating potential predictive biomarkers in the treatment of locally advanced and metastatic pancreatic cancer

This study looks at whether testing for 'biomarkers' may be used to select the best treatment for patients with metastatic pancreatic cancer. A biomarker is a biological characteristic that can be measured in tumour tissue or blood, which may provide information on the behaviour of cancer or help predict the likely effect of a given treatment. We know that not all cancers or patients are the same, and that some patients may respond better to certain treatments. This study will help increase our understanding of how we might be able to select treatments to suit individual patients and their cancers. By doing this we hope to obtain the best outcomes for future patients while minimising side effects from treatment. Who is it for? You can join this study if you have radiologically and histologically confirmed metastatic pancreatic adenocarcinoma, confirmed by biopsy. This is a phase II multicentre, randomised, open label study to evaluate biomarker directed treatment of metastatic pancreatic cancer. Trial Details Participants will be in two groups. Group 1 will receive Gemcitabine, and Group 2 will receive a combination of Oxaliplatin, Leucovorin and 5-fluorouracil (mFOLFOX6). Treatment will continue as long as it seems to be helping, provided participants do not have troublesome side effects. Through this study we hope to gain information about the following: 1) Can testing for hENT1 help us to identify patients who are more likely to benefit from initial treatment with gemcitabine chemotherapy? 2) Is it possible to do the tests in patients quickly enough to enable use in routine clinical practice? 3) How effective is FOLFOX chemotherapy as treatment for metastatic pancreatic cancer? 4) Are there any other biomarkers in cancer cells or blood that may help us determine the best drug to use against an individual cancer? This randomised phase II exploratory study is vital in understanding the optimal design of future studies evaluating this novel approach to the management of pancreatic cancer, and may be expanded to a phase III study if this approach is validated.