A trial looking at a drug called S 95005 with bevacizumab for bowel cancer (SOLSTICE)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is for people with bowel cancer that has spread to other parts of the body (metastatic). It is for people who:

are going to have treatment for metastatic bowel cancer for the first time
can’t have surgery to try to cure their cancer
can’t have treatment with a combination of chemotherapy drugs that contain irinotecan or oxaliplatin

More about this trial

Chemotherapy is a common treatment for bowel cancer that has spread to other parts of the body. You usually have a chemotherapy drug called capecitabine on its own, or in combination with a targeted drug called bevacizumab.

S 95005 is also a chemotherapy drug. It is known as trifluridine/tipiracil or by its brand name Lonsurf. S 95005 on its own is already a possible treatment for metastatic bowel cancer.

Doctors think that S 95005 can stop bowel cancer cells from making and repairing DNA. Cancer cells need to make and repair DNA so that they can grow and multiply.

Everyone taking part in this trial has 1 of the following:

S 95005 with bevacizumab (experimental treatment)
capecitabine with bevacizumab (standard treatment)

The main aim of this trial is to find out how well S 95005 and bevacizumab works for people with metastatic bowel cancer.

Who can enter

The following bullet points list 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 adenocarcinoma of the colon or rectum (bowel cancer)
you have at least one area of cancer that can be seen and measured on a scan
your doctor thinks that you can’t have surgery to try to cure your cancer or a combination of chemotherapy drugs that contain irinotecan or oxaliplatin
doctors have tested a tissue sample of your cancer for changes (mutations) to a gene called RAS
you can swallow and absorb tablets
you have satisfactory blood test results
you are at least 18 years old
you are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
you are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any possibility that you or your partner could become pregnant

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You:

have had treatment that reached your whole body (systemic treatment) such as chemotherapy for metastatic bowel cancer
have moderate or severe side effects from previous cancer treatment
have cancer spread in your brain or spinal cord (central nervous system) that is causing symptoms
have had radiotherapy in the past month
have had treatment with S 95005
have had treatment with a drug called sorivudine or any other similar drug in the last month
have had another cancer in the past 5 years, apart from non melanoma skin cancer or carcinoma in situ of the neck of the womb (cervix) that was successfully treated

Medical conditions

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

are taking part in another clinical trial looking at a new drug, or have had an experimental treatment in the past month
are going to have, or have had a major surgery in the last month
have problems with your digestive system that affects that way you absorb tablets
are unable to digest lactose (lactose intolerance)
have a severe infection that isn’t controlled
have or have had lung problems that can cause scarring of the lungs (interstitial lung disease)
have diabetes that isn’t controlled
have heart problems such as angina that isn’t stable, high blood pressure or an abnormal heart rhythm that isn’t controlled
have had a heart attack or a stroke in the past 6 months
have had fluid removed from your tummy (abdomen), lungs or heart in the last month
take drugs that damp down your immune system (immunosuppressants) unless it is a very small dose
have hepatitis B or hepatitis C
have HIV
have a serious wound or a fracture that hasn’t healed
have had a blood clot in a deep vein of your body (deep vein thrombosis) in the last month
have problems with the way your blood clots or you have had moderate or severe bleeding in the last month
have low levels of an enzyme called DPD (DPD deficiency)
have any other medical condition that the trial team thinks could affect you taking part

Other

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

are pregnant or breastfeeding
are sensitive to S 95005, bevacizumab, capecitabine or anything they contain
can’t have any of the drugs used in this trial for any reason

Trial design

This is an international phase 3 trial. Researchers hope that around 854 people worldwide and about 70 people from the UK will agree to take part.

It is a randomised trial. Everyone taking part is put into 1 of the following treatment groups by computer:

S 95005 and bevacizumab
capecitabine and bevacizumab

Neither you nor your doctor can choose which group you are in.

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S 95005 and bevacizumab

Everyone has S95005 and bevacizumab in cycles of treatment that last 4 weeks. The first day of each cycle is called day 1.

You take S 95005 as tablets that you swallow whole, twice a day. You should take them within 1 hour after your breakfast and dinner.

Bevacizumab comes as a drip that you have into your bloodstream (intravenously). It takes up to 60 minutes every time you have it.

You have S 95005 and bevacizumab in the following way:

you take S 95005 twice a day on days 1 to 5 and days 8 to 12
you have bevacizumab on day 1 and day 15
you have no treatment on days 15 to 28

You then start a new cycle of treatment. This continues for as long as treatment is helping you and the side effects aren’t too bad.

Capecitabine and bevacizumab

You have capecitabine and bevacizumab as cycles of treatment that last 3 weeks.

You take capecitabine as tablets that you swallow whole, twice a day. You should take them within 30 minutes after your breakfast and dinner. And have bevacizumab as a drip into your bloodstream.

You have each cycle of treatment in the following way:

you have bevacizumab on day 1
you take capecitabine tablets twice a day on days 1 to 14
you have no treatment on days 15 to 21

You then start a new cycle of treatment. This continues for as long as the treatment is helping you and the side effects aren’t too bad.

Quality of life questionnaires

Everyone taking part completes quality of life questionnaires before the start of treatment and then:

every 6 weeks during treatment
after you finish treatment

The questionnaires ask about how you are feeling and the side effects you might have. You complete the questionnaires on a tablet (electronically) when you are at the hospital.

Blood samples

You might have an extra blood test before the start of your treatment. Doctors want to look for a protein called BRAF that can help to tell how well treatment might work (BRAF status).

You don’t have to have an extra blood test if doctors already know your BRAF status.

Hospital visits

You see a doctor and have some tests before taking part. The tests you might have include:

a physical examination
CT scan or MRI scan
heart trace (ECG)
blood tests
urine test

During treatment, you see the trial team every 2 to 3 weeks. You have a physical examination and blood tests every time you see them. You also have a CT scan or MRI scan every 8 weeks.

Your treatment continues for as long as it is helping you and the side effects aren’t too bad.

When you finish treatment, you see the trial team after a month. You have blood tests, a heart trace and a physical examination. You then see or speak with the trial team every 2 months.

Side effects

The trial team will check you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the side effects before you start the treatment.

The most common side effects of S 95005 are:

loose or watery poo (diarrhoea)
loss of appetite
tiredness (fatigue)
a drop in the levels of red blood cells, white blood cells and platelets causing breathlessness, increased risk of infection and bleeding
feeling or being sick

Some people have low levels of an enzyme called DPD in their bodies. If you have this, you are more likely to have severe side effects from capecitabine. Speak to your doctor if you think you have this or have severe side effects from treatment.

We have information about the possible side effects of bevacizumab and capecitabine.