A study of 2 different combinations of chemotherapy before surgery for cancer of the pancreas (PRIMUS 002)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Pancreatic cancer
Status:
Closed
Phase:
Phase 2
This study is comparing FOLFOX-A chemotherapy with AG chemotherapy for pancreatic cancer. It is for people who are suitable to have surgery to remove the cancer.
The PRIMUS 002 study is part of a larger research programme looking at new treatments for cancer of the pancreas. To take part in Primus 002, you must have already joined a study called Precision-Panc. In this study, your doctor looked at the make up of your cancer and they have now matched you to have the treatment in this study.
Cancer Research UK supports this study.
More about this trial
Surgery is a usual treatment for pancreatic cancer that hasn’t spread to nearby organs or elsewhere in the body. This is called localised pancreatic cancer. You might also have chemotherapy or a combination of chemotherapy and radiotherapy. But there isn’t a standard way of treating localised pancreatic cancer.
Some research suggests having chemotherapy before surgery improves the chances of removing all the cancer. So, researchers are running this study to find out more. They are looking at having one of the following combinations of chemotherapy before surgery:
- FOLFOX and nab-paclitaxel (FOLFOX-A)
- gemcitabine and nab-paclitaxel (AG)
Gemcitabine and nab-paclitaxel (AG) are already used for cancer of the pancreas that has spread. FOLFOX-A is a newer combination of chemotherapy. It includes folinic acid and the chemotherapy drugs:
- fluorouracil (5FU)
- oxaliplatin
- nab-paclitaxel
The aims of the study are to:
- find the best way to treat localised pancreatic cancer
- predict who benefits most from chemotherapy before surgery
- learn more about the side effects of treatment
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all the following apply:
- you have joined the Precision-Panc study and there are some suitable tissue samples available for the study team to do some tests on
- you have a type of pancreatic cancer called ductal adenocarcinoma
- your cancer can be measured on a scan
- you can have surgery to remove the cancer
- you are fit enough to have surgery, chemotherapy and chemoradiotherapy
- it is possible to have a metal tube inserted into your bile duct if you develop a condition called jaundice
- you are well enough to carry out all your normal activities, apart from heavy physical work (performance status 0 or 1)
- you are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
- you have satisfactory blood test results
- you are at least 16 years old
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
- have cancer that has spread elsewhere in the body
- have had any other cancer apart from basal cell skin cancer or early cervical cancer that has been successfully treated
- have already had chemotherapy or chemoradiotherapy for pancreatic cancer
- have had an experimental treatment that hasn’t completely cleared your body
Medical conditions
You:
- have a heart problem that isn’t controlled with medication
- have an infection including chicken pox or herpes
- are overweight (body mass index of more than 35)
- have long term liver disease unless your liver is still working normally (Child-Pugh A)
- have had an exercise test that shows you aren’t a suitable candidate for surgery
- have had major surgery in the last 28 days
- have very bad diarrhoea that isn’t controlled with medication
- have had problems with the digestive system called malabsorption
- have a condition called DPD (stands for dihydropyridine dehydrogenase which means you can’t break down chemotherapy properly)
- have moderate to severe numbness or tingling in your hands or feet
- are having any antiviral treatment such as brivudine or sorivudine
- have a mental health problem or any other serious medical condition that means you can’t take part in the study
Other
You:
- are sensitive to any of the study drugs
- are pregnant or breastfeeding
Trial design
This is a phase 2 study. The study team need 242 people to take part.
The combination of chemotherapy you have depends on your age and how fit and well you are. Your doctor will decide which treatment is best for you.
You have 1 of the following:
- FOLFOX-A
- nab-paclitaxel and gemcitabine (AG group)
You have all your treatment as a drip into a vein. You have chemotherapy in cycles.
FOLFOX-A treatment group
Each 2 week period is a cycle of treatment. The first day of each treatment cycle is called day 1. You have all your treatment on day 1.
You have the nab- paclitaxel first and then have the oxaliplatin and folinic acid. This takes 2 and a half hours. Although you might be at hospital for longer than this. Then you start the 5FU.
You have the 5FU as a continuous infusion over 2 days. You have it through a small pump connected to either a central line or PICC line. You can carry the pump on a belt or in a bag. You can go home with the pump. The nurses will tell you how to look after it.
You have 6 cycles in total. This takes 3 months.
AG treatment group
Each 4 week period is a cycle of treatment.
You have treatment on:
- day 1
- day 8
- day 15
Treatment takes about an hour each time. You usually have this as a day patient and will be at the hospital for a few hours. You have 3 cycles in total. This takes 3 months.
Surgery
You wait 4 weeks before you have surgery. Before surgery you have blood tests and CT scans. This is to check your cancer hasn’t got worse and you are fit enough for surgery. You then go on to have your surgery as planned. Your doctor can tell you more about this.
Research samples
The study team will ask you to give a tissue sample:
- when you join the Precision-Panc study
- during surgery
You also give some extra blood samples. The researchers plan to use these to find out more about pancreatic cancer and how to treat it.
PET scan sub study
You have a PET scan before chemotherapy and before surgery. You don’t have to agree to take part if you don’t want to. You can still join the main study.
Hospital visits
You’ll see a doctor before you take part to have some tests. These include:
- blood tests
- physical examination
- heart trace (ECG)
- CT scan
- MRI scan of your liver
- an exercise test to check your heart and lung function
You see the doctor regularly through treatment:
- for blood tests
- a physical examination
- to see how you are
Follow up
You see the doctor for a check up:
- every 3 months in the 1st year
- every 6 months after that
You have blood tests and a CT scan at each visit.
Side effects
The most common side effects of both FOLFOX-A and AG are:
- a drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- feeling or being sick
- skin rash
- numbness or tingling in your hands or feet
- fluid loss (dehydration)
- hair loss or thinning
- tiredness (fatigue)
- headache
- shortness of breath
- cough
- nose bleeds
- stomach pain
- taste changes
- swelling
- dizziness
- fever or chills
- weight loss
- depression
- difficulty sleeping
- loss of appetite
- low levels of potassium in the blood
- liver changes
Some other very common side effects of FOLFOX-A are:
- a sore mouth
- an unpleasant sensation in the throat
- diarrhoea or constipation
- redness, swelling and pain on the palms of your hands and soles of your feet (palmar plantar syndrome)
- an allergic reaction, including a skin rash
Some other very common side effects of AG are:
- pain, swelling or sores on the inside of the mouth
- flu like symptoms
We have more information about:
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Dr Derek Grose
Supported by
Cancer Research UK
Cancer Research UK Clinical Trials Unit, Glasgow
NHS Greater Glasgow and Clyde
Celgene
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
15220
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
