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

Cancer type:

Bowel (colorectal) cancer
Secondary cancers

Status:

Open

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 Open a glossary item. 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 Open a glossary item 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 Open a glossary item or carcinoma in situ Open a glossary item 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 Open a glossary item 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 Open a glossary item that isn’t controlled 
  • have heart problems such as angina Open a glossary item that isn’t stable, high blood pressure or an abnormal heart rhythm that isn’t controlled 
  • have had a heart attack or a stroke Open a glossary item 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 Open a glossary item (immunosuppressants) unless it is a very small dose 
  • have hepatitis B or hepatitis C 
  • have HIV 
  • have a serious wound or a fracture  Open a glossary itemthat 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. 

 

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 Open a glossary item)
  • 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:
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

Location

Aberdeen
Bristol
Chelsea
Leeds
London
Manchester
Sutton

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 Mark Saunders

Supported by

Servier Research and Development Ltd
Institut de Recherches Internationales Servier

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16121

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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