A trial of ATRA and chemotherapy for pancreatic cancer (STARPAC-2 or PRIMUS-005)

Cancer type:

Pancreatic cancer

Status:

Open

Phase:

Phase 2

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.

 

More about 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:

  • find out if adding ATRA to chemotherapy helps to shrink locally advanced cancer
  • learn more about the side effects of treatment 
  • find out how treatment affects quality of life 

Who can enter

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:

  • have ductal adenocarcinoma of the pancreas that was confirmed with a tissue sample (biopsy Open a glossary item) from the Precision Panc trial. Or you had recent surgery and you were diagnosed with locally advanced pancreatic cancer.
  • have cancer that has spread to nearby tissues (locally advanced cancer Open a glossary item) just outside the pancreas and it isn’t possible to remove it with surgery
  • have cancer that your doctor can measure on a scan 
  • have had a CT scan and a PET-CT scan within 28 days of being put into a trial treatment group 
  • have satisfactory blood test results 
  • are willing to use reliable contraception during the trial and for a certain period after if there is any chance you or your partner could become pregnant
  • can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
  • are at least 16 years old 

Who can’t take part

Cancer related 
You cannot join this trial if any of these apply. You:

  • have cancer that has spread elsewhere in the body 
  • have already had treatment that reaches the whole body (systemic treatment Open a glossary item) for pancreatic cancer
  • have or have had another cancer unless you had treatment and there have been no signs of it for at least 2 years. You can join if it was successfully treated non melanoma skin cancer Open a glossary item, early bladder cancer, prostate cancer under active surveillance, or carcinoma in situ (CIS Open a glossary item) of the cervix 
  • are taking part in another trial of an experimental drug or device or you took part in one in the 30 days before you start trial treatment

Medical conditions
You cannot join this trial if any of these apply. You:

  • have numbness or tingling (peripheral neuropathy Open a glossary item) in your hands and feet unless it is mild 
  • have HIV, an active hepatitis B or hepatitis C infection or you have any other infection that needs treatment 
  • have had major surgery within 4 weeks of being put into a trial treatment group 
  • have a connective tissue problem such as lupus Open a glossary item. Your doctor will know about this. 
  • have scarring of the lung, lung inflammation or shortness of breath that is getting worse
  • have had a heart attack or a significant heart problem Open a glossary item in the last year. Your doctor checks your heart before you can take part. 
  • have a condition called peripheral artery disease 
  • are taking vitamin A supplements or any other medication you can’t have if you join this trial. The team check your medications before you can take part. 
  • have any other medication condition or mental health problem that the trial team think will affect you taking part 

Other 
You cannot join this trial if any of these apply. You:

  • have had a live vaccination Open a glossary item within 4 weeks of starting trial treatment 
  • are allergic to any of the drugs in the trial or anything they contain. This includes an allergy to soya beans or peanuts. 
  • are pregnant or breastfeeding

Trial design

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:

  • gemcitabine and nab-paclitaxel 
  • gemcitabine, nab-paclitaxel and ATRA 

You have treatment in cycles Open a glossary item. 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: 

  • have chemotherapy once a week for 3 weeks
  • don’t have it in the 4th week 

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 (biopsy Open a glossary item) 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.

Hospital visits

You see the doctor and have tests before you can take part. These include:

  • blood tests
  • a physical examination Open a glossary item 
  • heart trace (ECG Open a glossary item)
  • a test to see how your nerves are working
  • CT scan  
  • PET-CT scan or MRI scan of your liver 

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.

Side effects

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:

  • hair loss
  • an irregular heartbeat
  • changes to your eyesight or hearing
  • bone, joint, chest or tummy (abdominal) pain 
  • skin rash, itching, redness, peeling, inflammation or dry skin
  • swollen, dry or cracked lips or inflammation of the lips
  • breathing difficulties such as asthma, which may get worse
  • conjunctivitis or dry eyes
  • difficulty sleeping
  • sweating more than usual
  • headache or feeling dizzy
  • feeling tired, cold or generally unwell
  • feeling confused, worried or depressed
  • pins and needles or numbness of your hands or feet
  • loss of appetite
  • feeling or being sick, stomach upset or ache 
  • inflammation of the pancreas (pancreatitis)
  • diarrhoea or constipation
  • changes to your blood tests such as higher levels of fats (cholesterol)

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:

Location

Dorset
Edinburgh
London

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

Professor Hemant Kocher

Supported by

Celgene 
Medical Research Council (MRC)
Queen Mary University of London

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17302

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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