A study looking at nelfinavir and chemoradiotherapy for pancreatic cancer (SCALOP-2)

Cancer type:

Pancreatic cancer

Status:

Open

Phase:

Phase 2

This study is for people who have pancreatic cancer that hasn’t spread to other parts of the body but can’t be removed with surgery. We call this locally advanced cancer.   

There are 2 stages to this study. The first stage looked at finding the best dose of nelfinavir to have with chemoradiotherapy Open a glossary item.  The 2nd stage is looking at having this dose with chemoradiotherapy.

Cancer Research UK supports this trial.

More about this trial

Treatment for locally advanced pancreatic cancer is usually either chemotherapy alone or a combination of chemotherapy and radiotherapy (chemoradiotherapy). But these treatments do not get rid of the cancer and so doctors are looking at how they can improve these treatments.
 
In this study, doctors want to see if increasing the dose of radiotherapy works better. They also want to see if having a drug called nelfinavir with a chemotherapy and radiotherapy makes the treatment better. The chemotherapy drug you have in this trial is capecitabine.
 
Nelfinavir is a type of drug called an antiretroviral. It is a treatment for human immunodeficiency virus (HIV). Doctors think it might help radiotherapy to work better. They think that it does this by increasing the amount of oxygen and blood supply to the cancer.  This will make the cancer cells more sensitive to the effects of the radiotherapy.
 
The aims of this study are to:
  • find the best dose of nelfinavir
  • learn about the side effects of combining nelfinavir, capecitabine and radiotherapy
  • find out if increasing the dose of radiotherapy can help people live longer
  • find out if adding nelfinavir to chemoradiotherapy can delay the cancer coming back

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 enter
You may be able to join this study if all of the following apply. You:
  • have been diagnosed with pancreatic cancer and are unable to have surgery to remove this (locally advanced pancreatic cancer)
  • have a tumour that measures 6 cm or less
  • are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • have satisfactory blood test results
  • are aged 18 years or older
Women who take part and who could possibly become pregnant must be willing to use reliable contraception during their:
  • chemotherapy and for 1 month afterwards 
  • chemoradiotherapy and for 6 months afterwards 
Men who take part who have a partner who could possibly become pregnant must be willing to use reliable contraception during their:
  • chemotherapy and for 3 months afterwards
  • chemoradiotherapy and for 3 months afterwards 
Who cannot enter
You can’t join this study if any of these apply.
 
Cancer related
You:
  • have pancreatic cancer that can be removed by surgery
  • have a type of cancer of the pancreas called lymphoma or a neuroendocrine tumour
  • have cancer that has spread elsewhere in the body (metastatic disease)
  • have pancreatic cancer that has come back after surgery
  • have had any other cancer in the last 3 years, apart from carcinoma in situ of the cervix or basal cell skin cancer  that was successfully treated or another early stage cancer that was successfully treated and there haven’t  been any signs of any cancer for at least 3 years
  • have had radiotherapy to your upper abdomen Open a glossary item
  • have had any experimental treatment, including chemotherapy and immunotherapy, within 6 weeks of joining the study
Medical conditions
You:
  • are taking the following drugs and you are not able to stop them during the time you have chemoradiotherapy- sorivudine and analogues such as brivudine, methotrexate, allopurinol, dipyridamole
  • have any problem with your kidneys such as adult polycystic kidney disease or hydronephrosis that would stop you being able to have radiotherapy
  • have heart problems such as coronary artery disease which is not controlled by medication or you have had a heart attack or stroke in the last 6 months
  • have haemophilia A or B
  • have chronic hepatitis B or hepatitis C
  • have HIV
  • have low levels of a protein called DPD (this helps your body to break down chemotherapy)
  • have galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
  • have had a severe reaction to a group of chemotherapy drugs called fluoropyrimidine Open a glossary item
  • are sensitive or allergic to any of the study drugs or their ingredients
  • have any other serious medical condition or mental health problem that the trial team think could affect you taking part
Other
You:
  • are pregnant or breastfeeding

Trial design

This is a phase 2 study. It is in 2 stages. In the first stage doctors needed up to 27 people to take part. 
 
In the 1st stage the study team found the best dose of nelfinavir. They will use this dose in stage 2 of the study.
 
Stage 2
In this stage, the team need about 262 people to join the study. 
 
Everyone has a course of chemotherapy, you have the drugs gemcitabine and nab-paclitaxel . We call this combination of chemotherapy GEMABX. 
 
You have both drugs through a drip into a vein.  You have them once a week for 3 weeks then you have a week of no treatment. Each 4 week period is called a cycle of treatment
 
You have 3 cycles then you have a CT scan. This is so the doctors can see what is happening to your cancer.  
 
People whose cancer stayed the same or shrunk (responded) are put into 1 of 5 groups (randomised). 
 
People whose cancer has continued to grow or aren’t willing to be randomised are put into the observation group. 
 
Observation group
Your doctor will discuss with you what your best treatment options are. You will have regular follow up as part of the study. 
 
Randomisation
The study team need about 170 people to be randomised as part of the study. 
 
You have 1 more cycle of chemotherapy. Then you are put into 1 of 5 groups. Neither you nor your doctor can choose which group you are in. 
 
You will be put into one of the following treatment groups:
  • nelfinavir, capecitabine and 5½ weeks of radiotherapy
  • capecitabine and 5½ weeks of radiotherapy (standard treatment Open a glossary item)
  • nelfinavir, capecitabine and 6 weeks of radiotherapy at a higher dose
  • capecitabine and 6 weeks of radiotherapy at a higher dose
  • gemcitabine and nab-paclitaxel (GEMABX)

Chemoradiotherapy
People having chemoradiotherapy start it within 4 to 6 weeks of finishing your last dose of chemotherapy. The treatment will last for 5 ½ weeks or 6 weeks. Everyone has:
  • radiotherapy-  Monday to Friday
  • capecitabine tablets twice a day - Monday to Friday
Some people also have nelfinavir tablets twice a day. You start these 7 days before starting radiotherapy and you take them every day until the end of radiotherapy.

You take both capecitabine and nelfinavir after a meal, for example breakfast and an evening meal. Or with as much food you can manage. 

 
You record the days and times you take your tablets on a diary card the nurse gives you. A research nurse checks your diary card when you go for treatment. 
 
Further chemotherapy, no radiotherapy
In this group, you have 2 further cycles of gemcitabine and nab paclitaxel.
 
6 weeks after you finish treatment you have a CT scan. This is so the doctors can see how well the treatment has worked. You might be able to have surgery to remove any cancer that is left if the cancer has shrunk a lot. 
 
Quality of life
You fill in a questionnaire before you start treatment and at 5 other visits to the hospital. The questions ask about how you are feeling and any side effects you might have. This is a quality of life study. 
 
Tissue samples
The team will ask for a piece of tissue (biopsy Open a glossary item) form when you were first diagnosed. 
 
They might also ask for a small piece of tissue if your cancer gets worse while having treatment. You don’t have to agree to have this sample taken if you don’t want to. You can still take part in the main trial. 
 
The researchers use the tissue samples to find put more about pancreatic cancer and how to treat it. 
 
Blood samples
You have a blood sample taken before you start nelfinavir to make sure you are fit enough to have it. And 2 after you finish treatment to see how well your body coped with the drug.
 
You might also have to have an extra blood test when the doctors are checking to see if you are able to join the trial. You will only have this if there are no recent blood test results available. 
 
They will also ask for extra blood samples:
  • when you agree to take part in the trial
  • during treatment
  • after treatment has finished
  • if your caner gets worse
You don’t have to agree to have these blood tests if you don’t want to. You can still take part in the main trial. 
 
Researchers will use these samples to find out more about pancreatic cancer and how to treat it.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include:
  • blood tests
  • a physical examination
  • CT scan (if you haven’t had one done in the last 28 days) or a PET-CT scan
  • test to see how well your kidneys work, for example a 24 hour urine collection, if needed
You see the doctor regularly through treatment:
  • for blood tests
  • a physical examination
  • to see how you are
Once you have finished your treatment you see the doctors every 3 months for the first year. You have blood tests and a CT scan at these visits. After the first year your doctors will tell you how often they need to see you. They will also tell you what tests you need to have.

Side effects

The most common side effects of gemcitabine are:

  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • feeling or being sick 
  • skin rash
  • flu-like symptoms (headaches, muscle aches (myalgia), a high temperature and shivering)
  • swelling in your face, hands or feet
  • blood in your pee

The most common side effects of nab-paclitaxel (Abraxane) are:

The most common side effects of capecitabine are:

  • diarrhoea
  • feeling or being sick
  • mouth ulcers
  • loss of appetite
  • tummy (abdominal) pain
  • soreness, redness and peeling on the palms of the hands and soles of the feet (palmar - plantar syndrome)

The most common side effects of nelfinavir are:

  • wind (flatulence)
  • diarrhoea
  • skin rash
  • feeling or being sick
  • changes to your blood test results (full blood count and liver function tests)

The most common side effects of radiotherapy are:

  • tiredness
  • feeling or being sick
  • diarrhoea
  • skin reaction (redness or soreness)

We have more information about:

Your doctor will talk to you about the possible side effects of all treatments you might have. 

Location

Aberdeen
Bristol
Cambridge
Cardiff
Coventry
Guildford
Hull
Leeds
London
Norwich
Oxford
Plymouth
Sheffield

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 Somnath Mukherjee

Supported by

Cancer Research UK
Celgene Ltd
Experimental Cancer Medicine Centre (ECMC)
National Radiotherapy Trials Quality Assurance Group (RTTQA) 
NIHR Clinical Research Network: Cancer
Oxford Clinical Trials and Research Unit (OCTRU)
University of Oxford

Other information

This is Cancer Research UK trial number CRUK/07/040.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10078

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

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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