A phase 3 study comparing Acelarin (NUC-1031) with Gemcitabine for pancreatic cancer that has spread (ACELARATE)
Full title: A Phase III, open label, multicentre randomised clinical study comparing Acelarin (NUC-1031) with Gemcitabine in patients with metastatic pancreatic carcinoma
Why is this trial being carried out?
Pancreatic cancer that has spread to another part of the body is called metastatic or advanced pancreatic cancer. The chemotherapy drug gemcitabine is often used to treat advanced cancer. Sometimes the cancer can develop a resistance to the drug, meaning it no longer works.
The ACELARATE trial is comparing a new drug called Acelarin (NUC-1031) with gemcitabine to see which works better in fighting pancreatic cancer, and to compare the side effects of each. Acelarin is a more developed form of gemcitabine that aims to delay the cancer becoming resistant to treatment. Over time, some chemotherapy can stop working so well.
The ACLELARATE trial is randomised, which means that you will be randomly selected by a computer to have either Acelarin or gemcitabine treatment. Both treatments will involve having treatment once a week for three weeks, then no treatment on the fourth week. You may also be asked to give blood and tissue samples at the start and end of the trial so researchers can see how well the treatments are working.
Researchers want to find out which of the two treatments is more effective by:
- seeing if Acelarin is better than gemcitabine at controlling the cancer
- learning more about the side effects of each treatment
- seeing which treatment is better in improving the quality of someone’s daily life.
Who is the trial suitable for?
The ACELARATE trial may be suitable for you if you:
- have a type of pancreatic cancer called adenocarcinoma
- are not able to have surgery – although you may be able to take part if you have had surgery and the cancer has come back
- are not able to have a combination of radiotherapy and chemotherapy to treat your cancer
- have satisfactory blood test results – the trial team will discuss this with you.
It may not suitable for you if you:
- have already had chemotherapy, unless it was after surgery and more than 12 months ago
- have had radiotherapy in the last four weeks
- have any other serious medical conditions that might prevent you from taking part in the trial – the trial team will discuss this with you
- have had any other cancer in the past five years – this does not include being successfully treated for stage 1 pancreatic cancer
- are allergic to gemcitabine or Acelarin (NUC-1031).
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: December 2015
Recruitment end date: May 2018
Published April 2016
Review date April 2018
The ACELARATE trial is being carried out at:
- The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool
- Hammersmith Hospital, London
- The Royal Marsden NHS Foundation Trust, Chelsea, London
- The Royal Marsden NHS Foundation Trust, Sutton, Surrey
- Royal Surrey County Hospital, Guildford, Surrey
- Peterborough City Hospital, Peterborough
- Sussex Cancer Centre, Brighton
- The Beatson Cancer Centre, Glasgow
- Yeovil District Hospital
- Pilgrim Hospital, Lincolnshire
Professor Daniel Palmer, University of Liverpool
You can contact the ACELARATE trial co-ordinator:
Rachael Baxter, Cancer Research UK Liverpool Cancer Trials Unit, University of Liverpool
Telephone: 0151 794 8248
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 please visit the Liverpool Cancer Trials Unit website.
For references used to develop this information please email us.