A study looking at chemotherapy 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 (locally advanced cancer). This study is supported by Cancer Research UK.

There are 2 stages to this study. The first stage is looking at finding the best dose of a drug called nelfinavir to give alongside chemoradiotherapy Open a glossary item. This summary has the details of stage 1.

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 giving a drug called nelfinavir with a chemotherapy drug called capecitabine and radiotherapy makes the treatment better.

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 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 the first stage of this study are to

  • Find the best dose of nelfinavir to give
  • Learn about the side effects of combining nelfinavir, capecitabine and radiotherapy

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.

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 the time they have chemotherapy and for 1 month afterwards
  • During the time they have 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 the time they have chemotherapy and for 3 months afterwards
  • During the time they have chemoradiotherapy and for 3 months afterwards

You cannot join this study if any of these apply. 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. If you have had a recent previous cancer this must have been not pancreatic cancer, early stage, successfully treated and there must have been no 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
  • 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 coronary artery disease which is not controlled by medication, or 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
  • Have galactose intolerance, Lapp-lactose deficiency or glucose-galactose malabsorption
  • Have had a severe reaction to fluoropyrimidine therapies
  • Are sensitive or allergic to any of the trial drugs or their ingredients
  • Have any other serious medical condition or mental health problem that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 study. It is in 2 stages. In the first stage doctors need up to 27 people to take part.

Chemotherapy

You start by having a course of chemotherapy using the drugs gemcitabine and nab-paclitaxel (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. 

  • If the scan shows your cancer has not got any bigger and your doctor thinks you should have chemoradiotherapy you have 1 more cycle of chemotherapy.
  • If after the scan your doctor does not think you are suitable for chemoradiotherapy they will discuss other treatments with you.

Chemoradiotherapy

You start chemoradiotherapy within 2 to 4 weeks of finishing your last dose of chemotherapy.  The treatment will last for 5 ½ weeks. You have

  • Radiotherapy- Monday to Friday
  • Capecitabine tablets twice a day- Monday to Friday
  • Nelfinavir tablets twice a day. You start these 7 days before starting radiotherapy and you take them every day until the end of radiotherapy

The doctors will be trying different doses of nelfinavir. The first few patients taking part will have a moderate dose. If they don’t have any serious side effects, the next few patients will have a higher dose. If people do not manage the moderate dose for any reason then the doctors will give a lower dose.

When the best dose is found this will be used in second stage of the trial.  This dose will be used in a larger number of people and tested against other treatments.

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.

6 weeks after you finish the chemoradiotherapy you have a CT scan. This is so the doctors can see how well the treatment has worked. If the cancer has shrunk a lot then it may be possible for you to have surgery to remove any cancer that is left. 

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)

You go to hospital to have your chemotherapy and your chemoradiotherapy. You should not need to stay overnight.

During the time you are in the study you have regular blood tests. These are to check that you are able to have treatment. 3 to 4 samples will be in addition to the ones you would usually have.

You have 1 before you start nelfinavir to make sure you are fit enough to have this 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.

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

Location

Bristol
Cambridge
Cardiff
Guildford
Leeds
London
Oxford

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.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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