A phase 3 trial looking at a new drug called PEGPH20 combined with two chemotherapy drugs: nab-paclitaxel (Abraxane®) and gemcitabine (Gemzar®) for pancreatic cancer that has spread (HALO).
Full title: A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High metastatic (stage 4) Previously Untreated Pancreatic Ductal Adenocarcinoma.
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. The chemotherapy drug gemcitabine is a standard treatment for advanced pancreatic cancer, and can be combined with the chemotherapy drug nab-paclitaxel (Abraxane®).
Researchers are looking at whether this type of chemotherapy might work better if a new drug called PEGylated Recombinant Human Hyaluronidase (PEGPH20) is used with nab-paclitaxel and gemcitabine. PEGPH20 is an enzyme that breaks down a substance called hyaluronan (HA). Hyaluronan can be found in pancreatic cancer, and helps it to grow. Research suggests that using PEGPH20 with nab-paclitaxel and gemcitabine can slow the growth of pancreatic cancer.
The HALO trial wants to:
- find out if nab-paclitaxel and gemcitabine work better in controlling the growth of advanced pancreatic cancer when combined with the new drug PEGPH20
- learn more about any side effects of this treatment.
The trial is suitable for people with advanced pancreatic cancer who have not already had chemotherapy for their advanced cancer, and who have high levels of HA. You can take part if you have had chemotherapy for pancreatic cancer at an earlier stage after surgery, or for locally advanced pancreatic cancer. Any chemotherapy that you have had before should have finished at least six months ago.
A sample of your tumour tissue is tested to see if you have high levels of HA and are suitable for this trial. It can include tissue that was taken when you were first diagnosed with pancreatic cancer. Or it could be tissue taken during surgery if your surgeon started to operate but found that your cancer had started to spread and was not operable. Or you may need to have a fresh biopsy to take a tissue sample, usually from the liver if the cancer has spread there, to test for HA.
You will also have tests to see if you are at risk of getting a blood clot. People who are at high risk of getting a blood clot will not be able to take part in the trial. This is because PEGPH20 can increase the risk of blood clots. Everyone taking part in the trial will inject themselves daily with a blood thinning (anti-coagulant) injection to help reduce the risk of blood clots.
This is a placebo controlled study. This means that everyone on this trial will receive nab-paclitaxel and gemcitabine. In addition, you will either have the new drug PEGPH20 or a dummy drug (placebo). This will be decided randomly by a computer.
What does this treatment involve?
Each cycle will last four weeks.
- For the first cycle, you will have PEGPH20 twice a week for three weeks, with the fourth week off.
- You will then have PEGPH20 once a week for three weeks, with a week off, for each future cycle.
- You will also have nab-paclitaxel and gemcitabine once a week for the first three weeks of all treatment cycles.
Treatment will continue as long as it is making you feel better.
Who is the trial suitable for?
The HALO trial may be suitable for you if:
- you have cancer that has spread to other parts of the body (advanced pancreatic cancer)
- you have cancer that can be seen on a CT scan
- you have pancreatic cancer that has spread after having chemotherapy or radiotherapy, and the treatment was at least six months before the trial starts
- you are fit and well enough to take part in the trial – you will have tests to check this.
The HALO trial may also be suitable for you if the trial team are able to get the right amount of tumour sample needed to test for HA. Only people whose tumours have high levels of HA will be treated in this trial. Up to four out of ten people with tumours (40%) are likely to have high HA.
It may not be suitable for you if you:
- have a blood clot (deep vein thrombosis or DVT) or a blockage of the artery to the lungs (pulmonary embolism or PE)
- have had cancer that has spread to the spine or brain
- have already had radiotherapy, surgery or chemotherapy to treat advanced pancreatic cancer– this does not include radiotherapy to control symptoms of the cancer
- have had any significant heart disease in the past 12 months.
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: September 2016
Recruitment end date: March 2018
Published January 2017
Review date March 2018
The HALO trial is being carried out in:
- Addenbrooke’s Hospital, Cambridge
- Peterborough and Stamford Hospitals, Peterborough
- Beatson West of Scotland Cancer Centre, Glasgow, Scotland
- Edinburgh Cancer Western General Hospital, Scotland
- Sarah Cannon Research UK, London
- Queen Elizabeth Hospital, Birmingham
- University Hospitals Coventry and Warwickshire NHS Trust, West Midlands
- Hammersmith Hospital, London
- James Cook University Hospital, Middlesbrough, North Yorkshire
- North Wales Cancer Treatment Centre, Wales
Dr Pippa Corrie, Addenbrooke’s Hospital, Cambridge
You can contact these trial centres here:
Addenbrooke’s Hospital, Cambridge: Dr Pippa Corrie, Email: email@example.com
Beatson West of Scotland Cancer Centre, Glasgow, Scotland: Professor Jeff Evans, Email: firstname.lastname@example.org
Edinburgh Cancer Western General Hospital, Scotland: Dr Alan Christie, Email: email@example.com
Peterborough and Stamford Hospitals, Peterborough: Karen McAdam, Email: Karen.McAdam@pbh-tr.nhs.uk
Hammersmith Hospital, London: Sarah Stimpson, Email: Sarah.firstname.lastname@example.org
North Wales Cancer Treatment Centre, Wales: Dr Angel Garcia, Email: Angel.Garcia@wales.nhs.uk
Sarah Cannon Research UK, London: Dr Tobias Arkenau, Email: email@example.com
University Hospitals Coventry and Warwickshire NHS Trust, West Midlands: Dr Martin-Scott, Email: Martin.Scott-Brown@uhcw.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 please visit the ClinicalTrials.gov website.
For references used to develop this information please email us.