
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
This trial is looking at having ATRA with gemcitabine and nab-paclitaxel chemotherapy for pancreatic cancer.
It is for people whose cancer has grown just outside the pancreas and it isn’t possible to have surgery to remove it.
The STARPAC-2 trial is also called Primus-005. The trial is part of a large research programme looking at new treatments for cancer of the pancreas. It is called Precision-Panc. To take part in this trial most people will have already joined a study called Precision Panc. In this study, the researchers were looking at the make up of your cancer. The information they found out means that they can match you to treatment in this trial. |
You might have chemotherapy to treat cancer of the pancreas that has spread to other parts of the body. One combination of chemotherapy is nab-paclitaxel and gemcitabine.
Pancreatic cancer that has grown into nearby tissues is locally advanced cancer. In some cases it isn’t possible to have surgery to remove it as it might block or surround major blood vessels. There isn’t a standard chemotherapy or radiotherapy treatment available to shrink the cancer enough to have surgery. Doctors are looking for ways to improve treatment for this group of people
Doctors know that thick scar tissue called stroma surrounds pancreatic cancer. This can block chemotherapy drugs from reaching the cancer.
We know from research that it is possible to weaken the stroma with vitamin A. This might allow the chemotherapy to get to the cancer cells. ATRA is similar to vitamin A.
ATRA is already a treatment for a type of blood cancer.
In this trial some people have gemcitabine and nab-paclitaxel. And some have ATRA, gemcitabine and nab-paclitaxel.
The main aims of this trial are to:
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
Medical conditions
You cannot join this trial if any of these apply. You:
Other
You cannot join this trial if any of these apply. You:
This phase 2 trial is taking place in the UK. The team need to find 170 people to take part.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in.
There are 2 treatment groups. You have 1 of the following:
You have . Each cycle of treatment is 4 weeks.
Chemotherapy only group
You have gemcitabine or nab-paclitaxel as a drip into a vein. This takes about 2 hours each time. You:
You have gemcitabine and nab-paclitaxel for as long as it is helping you and the side effects aren’t too bad.
Chemotherapy and ATRA group
You have chemotherapy as described above.
ATRA is a capsule. You take it twice a day for the first 15 days of each cycle. Then you have a break for 13 days. The team give you a diary to record when you take your capsules. You have ATRA for about 6 months in total.
Samples for research
You give extra blood samples as part of the trial. Where possible the team take these when you have your routine blood tests.
The team ask for a piece of a tissue sample () you gave for the Precision Panc trial. They may ask to take a new sample if this isn’t available.
The team also ask for 1 extra tissue sample during the trial and when you finish treatment. You can say no to these samples if you don’t want to give them. It won’t affect you taking part in the rest of the trial.
They will use these samples to learn more about pancreatic cancer and treatment for it.
You see the doctor and have tests before you can take part. These include:
You have the chemotherapy at the hospital on the day care ward.
Trial scans
You have a CT scan every 8 weeks. You stop having the trial scans if your cancer gets worse.
Follow up
When you finish treatment you see the doctor 1 month later for a check up. You then see them every 3 months or they may call you at home to see how you are getting on.
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The most common side effects of ATRA include:
The trial team will talk to you about all the possible side effects of treatment before you join the trial. You’ll have a chance to ask any questions you may have.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Hemant Kocher
Celgene
Medical Research Council (MRC)
Queen Mary University of London
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”