Summary title: PRIMUS-001: A phase II study comparing FOLFOX and nab-paclitaxel chemotherapies to gemcitabine and nab-paclitaxel for pancreatic cancer that has spread to other parts of the body
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
Why is this trial being carried out?
Pancreatic cancer that has spread to other parts of the body is called advanced or metastatic pancreatic cancer. Surgery isn’t possible if the cancer has spread, but you may be able to have chemotherapy.
The PRIMUS-001 trial will compare two different combinations of chemotherapy to see which works better, and which causes more side effects. Half the people taking part will have FOLFOX and nab-paclitaxel, and half will have gemcitabine and nab-paclitaxel. This is a randomised trial, so people taking part will be randomly selected to have one treatment or the other. You and your doctor will know which treatment you are receiving. You can ask the research nurse what the treatment you have been selected for will involve.
This trial is part of the Precision Panc study. This means that you will need to join the Precision Panc study and provide blood and tissue samples in order to take part in the PRIMUS-001 trial. Researchers will use these samples to look at the genetic changes in your cancer. They want to see if differences in the genes affect how well the treatments work. Read more about the Precision Panc study.
Who is the trial suitable for?
The PRIMUS-001 trial may be suitable for you if you:
- are taking part in the Precision Panc study
- have advanced pancreatic cancer
- are well enough to take part – you will have tests to check this
- have not previously had chemotherapy for advanced pancreatic cancer.
Who is it not suitable for?
The PRIMUS 001 trial is not suitable for you if you have already had chemotherapy for advanced pancreatic cancer, including nab-paclitaxel and oxaliplatin. But you may be able to take part if you have had gemcitabine, capecitabine or 5FU following surgery to try to remove the cancer (adjuvant chemotherapy), as long as it was at least six months ago and you no longer have side effects.
It is also not suitable for you if you:
- have neuropathy (tingling or pins and needles in your fingers and toes) that affects how well your fingers and toes work
- have severe diarrhoea (runny poo) that can’t be controlled
- currently have an infection, including herpes or chickenpox
- have a heart condition or other serious medical condition that isn’t controlled with treatment
- have had chemotherapy or major surgery within 28 days of joining the study, or radiotherapy or minor surgery within 7 days of joining it
- have had another cancer in the last five years, except some skin cancers, early cervical cancer and early prostate cancer.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you.
Recruitment start date: 01 Sep 2017
Recruitment end date: 30 Jun 2021
Published February 2018
To be reviewed February 2020
The PRIMUS-001 trial is being carried out in:
- Beatson West of Scotland Cancer Centre
- Aberdeen Royal Infirmary
- The Royal Marsden, London
- The Royal Marsden, Surrey
- University College Hospital, London
- The Christie, Manchester
You can contact the trial centres:
Judith Dixon-Hughes: firstname.lastname@example.org
Beatson West of Scotland Cancer Centre: Annette.Charlick@ggc.scot.nhs.uk
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial go to the UK Clinical Trials Gateway website.
For references used to develop this information please email us.