A trial looking at Acelarin and gemcitabine for pancreatic cancer that has spread (ACELARATE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing a new drug called Acelarin with gemcitabine for people with pancreatic cancer. It is for people whose cancer has spread elsewhere in the body (metastatic pancreatic cancer). This trial is supported by Cancer Research UK.
More about this trial
Doctors often use chemotherapy to treat pancreatic cancer that has spread. One of the drugs used is gemcitabine.
Acelarin is a type of chemotherapy. It is a similar drug to gemcitabine, but scientists have made changes to it to try to stop the cancer building up a resistance to the drug.
Researchers think Acelarin may work better than gemcitabine and have fewer side effects. To find this out, people in this trial will have treatment with either Acelarin or gemcitabine.
You usually have Acelarin into a central line or PICC line. You have the line put in before you start treatment and it then stays in for the whole time you are on treatment. Most people who have Acelarin in this trial will have it into their central line or PICC line.
As part of a sub study, a small number of people will have Acelarin through a drip into a small tube (cannula) in a vein. This is usually a vein in in the arm or back of hand. Doctors want to find out if people can have Acelarin safely in this way.
The trial team will check the cannula site to make sure that it is comfortable and there is no redness or swelling. If it is possible to have Acelarin into a vein, people in the future might not have to have a central line or PICC line put in.
The aims of this trial are to:
- find out whether Acelarin or gemcitabine is better at controlling the growth of pancreatic cancer
- find out if it is possible to have Acelarin into a vein
- learn more about the side effects of each treatment and how this affects quality of life
Who can enter
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
- Have a type of exocrine pancreatic cancer called adenocarcinoma or undifferentiated cancer of the pancreas
- Have cancer that has spread elsewhere in your body (stage 4 pancreatic cancer)
- Are unable to have surgery to cure your cancer – you may be able to take part if you have had surgery to remove your cancer and the cancer has come back
- Are unable to have a combination of radiotherapy and chemotherapy to treat your cancer
- Have cancer that can be measured using scans
- Have had a CT scan of your chest, tummy and the area between your hips (pelvis) in the last 4 weeks – if you have not had a recent scan the trial team will arrange one for you
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during the trial treatment and for 6 months after treatment in this trial if there is any chance that you or your partner could become pregnant
You cannot join this trial if any of these apply. You
- Have cancer that has spread to your brain
- Have already had chemotherapy for your cancer that has spread – you may be able to take if you had chemotherapy after surgery (known as adjuvant chemotherapy) and this was more than 12 months ago
- Have radiotherapy in the last 4 weeks
- Have had any other cancer in the last 5 years apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated
- Are allergic to the drugs used in this trial
- Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
- Are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. The researchers need 328 people to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- One group has Acelarin
- The other group has gemcitabine
Acelarin
The way you have Acelarin depends on whether you are part of the main treatment group, or the sub study.
Main treatment group
You have Acelarin through a drip into your central line or PICC line.
Acelarin is put into a bag of fluid. A pump then gives continuous amounts of the drug into your central line or PICC line until the bag is empty.
Acelarin sub study
The trial team need 30 people to join the join the sub study.
You have Acelarin through a drip into a small tube (cannula) put into your vein, usually into your arm or back of hand.
After each treatment, you stay in the clinic for about 1 hour. Your nurse monitors your cannula and vein to check for any pain, redness or swelling. The exception to this is after your first visit when you stay in clinic for about 2 hours. This is so that you can have an extra blood test following your first treatment with Acelarin.
Gemcitabine
You have gemcitabine through a drip into your central line or PICC line.
Each treatment of Acelarin or gemcitabine takes about 30 minutes. Everyone has treatment once a week for 3 weeks, then no treatment in the 4th week. Each 4 week period is called a cycle of treatment.
If you don’t have any serious side effects, you can continue treatment as long as your doctor thinks it is helping you.
The trial team will ask you to fill out 2 questionnaires:
- before you start treatment
- once during every cycle of treatment
- every 3 months once you have finished treatment
The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The team will ask your permission to look at a sample of your cancer removed when you had surgery or a biopsy. If a sample is not available for testing, they may ask you to have a sample taken of your cancer.
The trial team would also like to take extra blood samples
- at the start and finish of the trial
- on the first day of every cycle of treatment
- 40 minutes and 2 hours after each treatment of Acelarin or gemcitabine on day 1 of treatment only
These would be in addition to the routine blood tests you have as part of your care.
The researchers will use these cancer and blood samples to look for biomarkers to find out why treatment might work for some people and not for others. You do not have to agree to these extra samples if you don’t want to. You can still take part in the trial.
Hospital visits
You will see the doctors and have some tests to decide whether you are able to take part in this trial. The tests include:
- blood tests
- physical examination
- heart trace (ECG)
You may have a CT scan of your cancer if you have not had one in the last 4 weeks. If you go on to have treatment in this trial, you have a CT scan every 3 months.
During treatment you go to hospital at least 3 times over each 4 week cycle. You see a doctor before each treatment and have some blood tests. The doctor will ask how you are and whether you have any side effects.
Almost all the tests you have as part of this trial you would have as part of your routine care. The exception to this is the ECG and the extra blood tests and sample of your cancer.
If your cancer starts to grow again, you will finish treatment as part of this trial. You then have a further ECG. You continue to see your doctor and have a scan every 3 months.
Side effects
As Acelarin is a new drug, there may be side effects we don’t know about yet. The trial team will monitor you closely while you are having your treatment. You will have a contact number to ring if you have any questions or concerns while at home.
Possible side effects include:
- taste changes
- feeling or being sick
- ankle swelling
- constipation
- diarrhoea
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- a change to the way your kidney and liver works. You will have blood tests before and during your treatment to check your kidneys and liver
If you have Acelarin into your vein, it is possible that you might have a reaction at your cannula site. You might have:
- pain
- redness
- swelling
If people have a reaction, this is usually mild. The nurse will monitor the site closely and slow or stop treatment if you have a reaction. If necessary you can have further treatments into a central line or PICC line.
The most common side effects of gemcitabine are:
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- tiredness and weakness (fatigue)
- temporary swelling in your face, hands and feet
- flu like symptoms
- wheeziness and breathlessness soon after the drug. The nurse will keep a close eye on you and treatment your symptoms if this happens
- skin rash
- hair thinning
- changes to the way your liver works
We have more information about gemcitabine.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Daniel Palmer
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NuCana Biomed Ltd
The Clatterbridge Cancer Centre NHS Foundation Trust.
Other information
This is Cancer Research UK trial number CRUKE/15/013
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
