PRIMUS 001 (version 1)
Research type
Research Study
Full title
PRIMUS 001 - An adaptive phase II study of FOLFOX-A (FOLFOX and nab-paclitaxel) versus AG (nab-paclitaxel and gemcitabine) in patients with metastatic pancreatic cancer, with integrated biomarker evaluation
IRAS ID
221370
Contact name
Janet Graham
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Eudract number
2016-004155-67
ISRCTN Number
ISRCTN75002153
Duration of Study in the UK
4 years, 9 months, 31 days
Research summary
Most patients with metastatic pancreatic cancer survive less than one year however there are a small proportion of patients who live over 3, and sometimes >5 years from diagnosis. We think this might be because their tumours have defects in genes which are important for repairing DNA eg BRCA1/2 and other Fanconi Anaemia genes and that this might mean they are more likely to respond to DNA-damaging chemotherapy such as platinum (in this trial we are using oxaliplatin).
The PRIMUS 001 study aims to identify patients who are more likely to respond to platinum based treatments, based on additional lab tests performed on a biopsy sample. The trial will compare FOLFOX A which contains oxaliplatin to the standard of care AG (nab-paclitaxel + gemcitabine).
Abraxane and oxaliplatin can both damage patients nerves and cause symptoms such as tingling in finger tips and toes. We are therefore keen to ensure that if this combination does cause better responses or give extra time that this does not come at the cost of impaired quality of life. As a result there are several Quality of life questionnaires used throughout the study. Patients who join the study can continue on treatment for as long as it is effective and they wish to continue.
REC name
West of Scotland REC 1
REC reference
17/WS/0142
Date of REC Opinion
1 Aug 2017
REC opinion
Further Information Favourable Opinion