A study of FOLFOX-A chemotherapy for cancer of the pancreas that has spread (PRIMUS 001)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is comparing FOLFOX-A chemotherapy with AG chemotherapy for pancreatic cancer that has spread elsewhere in the body. It is for people who haven’t had treatment for pancreatic cancer that has spread.
The Primus 001 study is part of a large research programme looking at new treatments for cancer of the pancreas. To take part in Primus 001, 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 trial.
Cancer Research UK supports this trial.
More about this trial
- nab paclitaxel
- gemcitabine
- fluorouracil (5FU)
- oxaliplatin
- nab paclitaxel
- find out if FOLFOX-A keeps the cancer under control for longer compared with standard treatment
- learn more about the side effects
- find out more about
quality of life
Who can enter
- 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 cancer of the pancreas that has spread elsewhere in the body and these areas can be measured on a scan
- you haven’t had any anti cancer treatment for cancer spread
- you can look after yourself, 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
- have cancer spread to your brain that isn’t stable
- have already had chemotherapy for cancer spread elsewhere in the body (you might be able to take part if you had fluoropyrimidine and gemcitabine after surgery and this was at least 6 months ago)
- have had an experimental treatment that hasn’t completely cleared your body
- have had any anti cancer treatment or major surgery within 28 days of joining the study
- have had any other cancer in the last 3 years apart from
non melanoma skin cancer that you have had treatment for, early cervical cancer or early prostate cancer that you have had treatment for or it is stable
Medical conditions
You:
- have a heart problem such as fluid around the heart (congestive heart failure), a heart attack or angina that isn’t well controlled
- have had a stroke or mini stroke (TIA)
- have an active infection including herpes or chicken pox
- are having any antiviral treatment such as brivudine or sorivudine
- have very bad diarrhoea
- have moderate to severe numbness or tingling in your hands or feet
- have a condition called DPD (stands for dihydropyridine dehydrogenase which means you can’t break down chemotherapy properly). People with a partial DPD deficiency are suitable for the study.
- have a mental health problem or medical condition that means you can’t take part in the study
- are sensitive to any of the study drugs
- are pregnant or breastfeeding
Trial design
- FOLFOX-A
- nab paclitaxel and gemcitabine (AG group)


- day 1
- day 8
- day 15
- before starting treatment
- 2 months after treatment starts
- if your cancer starts to grow again

- detect if cancer comes back
- check how well treatment is working rather than using CT scans
Hospital visits
- blood tests
- physical examination
- heart trace (
ECG) - CT scan
- 3 months in the first year
- 6 months in the second year
- then once a year for the following 3 years
Side effects
- 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
- 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
- an allergic reaction, including a skin rash
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
Dr Janet Graham
Supported by
Cancer Research UK
NHS Greater Glasgow and Clyde
Celgene
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040