A trial hoping to make chemotherapy more effective for locally advanced pancreatic cancer (STARPAC or PRIMUS-005).
Research title: A phase 2 randomised clinical trial repurposing ATRA as stromal targeting agent along with gemcitabine and nab-paclitaxel for locally advanced pancreatic cancer.
You may hear this trial called PRIMUS-005. PRIMUS trials are linked to Precision Panc.
Why is this trial being carried out?
Locally advanced pancreatic cancer is cancer that has spread just outside of the pancreas. It may have spread to areas near the pancreas, such as the spleen, stomach or large blood vessels. If you have locally advanced cancer, it isn’t usually possible to remove the cancer with surgery. You may be offered chemotherapy to try to slow down the growth of the cancer.
Pancreatic cancer is surrounded by tissue called stroma. The stroma can make it harder for chemotherapy drugs to get to the cancer cells in the pancreas. This trial is looking at a drug called ATRA (All Trans Retinoic Acid) which is known to weaken the stroma. ATRA is used for some types of blood cancer, and it has been used in a small number of people with pancreatic cancer.
It is hoped that giving ATRA with chemotherapy will mean that the chemotherapy drugs can reach the cancer cells more easily. The STARPAC-2 trial will see if ATRA can make chemotherapy for locally advanced pancreatic cancer work better at slowing down the growth of the cancer.
In the STARPAC-2 trial, people taking part will either have:
• gemcitabine and nab-paclitaxel (Abraxane®) chemotherapy on its own
• or gemcitabine and nab-paclitaxel (Abraxane®) chemotherapy plus the drug ATRA.
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 STARPAC-2 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 Precision Panc.
Who is the trial suitable for?
The STARPAC2 may be suitable for you if you:
• have locally advanced pancreatic ductal adenocarcinoma (PDAC)
• haven’t had chemotherapy or immunotherapy to treat your cancer
• are taking part in the Precision-Panc study
• are well enough to take part – you will have tests to check this.
The STARPAC2 trail may not be suitable for you if:
• you have advanced pancreatic cancer
• you have had major surgery in the last 4 weeks – this doesn’t include surgery to take a biopsy
• you have had another type of cancer in the last two years, unless this was some types of skin, bladder, prostate or cervical cancer – your doctor can tell you more
• you have other health conditions that could make this trial unsafe for you, including lung disease or if you have a high risk of heart disease – your doctor can tell you more about this
• you have taken part in another clinical trial in the last 30 days
• you have had a live vaccine in the last 4 weeks
• you have an uncontrolled infection that needs treatment – this includes uncontrolled HIV and hepatitis B or C.
There may be other reasons for not being able to take part in this trial. It is important to speak to your oncologist (cancer doctor) about whether this trial might be suitable for you.
What does the trial involve?
If you are able to take part in this trial you will have treatment with either:
• gemcitabine and nab-paclitaxel (Abraxane®) chemotherapy
• or gemcitabine and nab-paclitaxel (Abraxane®) chemotherapy plus ATRA.
The treatment you have will be randomly chosen so that half of the people taking part in the trial will receive one of the treatments, and the other half will receive the other treatment. This is so that the treatments can be compared fairly, and is called a randomised controlled trial.
These treatments will be given in 4 week cycles, where you will have treatment for 3 weeks and then have a break from treatment for 1 week.
How are the chemotherapy drugs given?
The chemotherapy drugs gemcitabine and nab-paclitaxel (Abraxane®) are given through a drip into your vein. You will need to go to the chemotherapy day unit at the hospital once a week for 3 weeks to have these drugs. Having this chemotherapy should take around 2 hours each week.
How is ATRA given?
ATRA is a capsule that needs to be taken twice a day with a meal, or shortly after a meal. It may be best to take one in the morning and one in the evening. The first time you take ATRA it will need to be at the hospital when you go in for your chemotherapy, but after this you can take the ATRA capsules at home.
You are able to have ATRA for 6 months. If you are having chemotherapy on its own, you can have this until it stops working for you, you have bad side effects, or you choose to stop this treatment.
Recruitment start date: 1st December 2020
Recruitment end date: 31st March 2023
The STARPAC-2 trial is being carried out in:
Queen Mary University of London
Barts Health NHS Trust, Whitechapel Rd, London, Whitechapel E1 1BB
Professor Hemant Kocher
You can contact the trial centre by emailing: email@example.com
How to join a trial
Speak to your oncologist (cancer doctor) 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 ClinicalTrials.Gov website.
For references used to develop this information please email us.