A study of new treatments for bowel cancer that has spread elsewhere in the body (TASCO1)

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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

Status:

Closed

Phase:

Phase 2

This study is looking at a new chemotherapy drug called S 95005. It is for people who

have bowel (colorectal) cancer that has spread to another part of the body and it isn’t possible to remove these areas with an operation
aren’t fit enough to have intensive treatment

More about this trial

Bowel cancer that has spread to another part of the body is called advanced or metastatic bowel cancer. Chemotherapy is the usual treatment if the cancer can’t be removed. This can be intensive and may include 3 or 4 different drugs.

If you are not strong enough for intensive treatment you may be better off having 1 or 2 drugs. You might have the chemotherapy drug capecitabine, alongside a monoclonal antibody Open a glossary item called bevacizumab. This is standard treatment .

S 95005 is a new chemotherapy drug. The researchers think it might be a useful treatment alongside bevacizumab. But they want to find out more.

In this study, some people have S 95005 and bevacizumab. And some have capecitabine and bevacizumab.

The aims of the study are to

find out which treatment works best
learn more about the side effects

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 might be able to join this study if all of the following apply.

You have cancer of the colon or rectum that has spread to another part of the body no more than 6 months ago
It isn’t possible to remove the areas of cancer spread with an operation
You have at least 1 area of cancer spread that can be seen on a scan
The study team can find out if the bowel cancer cells have a change (mutation ) to the RAS gene or not
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have satisfactory blood test results
You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you or your partner could become pregnant
You are at least 18 years old

You cannot join this study if any of these apply.

You have already had treatment for advanced bowel cancer. If you had chemotherapy before or after surgery you might be able to take part if it finished more than 6 months ago
Your doctor thinks you are suitable to have chemotherapy with oxaliplatin or irinotecan
You have cancer that has spread to the brain or to the membranes surrounding the brain (leptomeningeal metastasis)
You have had treatment with an experimental drug in the last 4 weeks
You have already had S 95005 or you are allergic to anything it contains
You have had any other cancer in the last 5 years apart from very early cancers that were successfully treated
You have problems with your heart, such as a heart attack in the last year, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart failure that is causing symptoms
You have had a stroke
You have a lung condition called pulmonary fibrosis or interstitial pneumonitis
You have diabetes that isn’t well controlled with medication
You have had a blood clot in your leg or lung or you have had a major bleed in the 3 weeks before starting study treatment
You have a blockage in your bowel
You have a problem with the way your blood clots that could increase the risk of bleeding
Your kidneys and liver aren’t working properly
You have an autoimmune disease or you have had an organ transplant and you need to take steroids to dampen down your immune system
You have had major surgery in the last 4 weeks
You have had radiotherapy to large area in the last 4 weeks or to a smaller area in the last 2 weeks
You have an active infection
You are known to have HIV, hepatitis B or hepatitis C
You have any other serious medical condition or mental health problem that the study team think could affect you taking part
You are pregnant or breastfeeding

Trial design

This is an international phase 2 study. The study team need about 40 people in the UK to take part.

The study is randomised. You are put into 1 of 2 treatment groups by computer. Neither you nor your doctor will be able to decide which group you are in.

one group have S 95005 and bevacizumab
the other group have capecitabine and bevacizumab

Study Diagram

S 95005 and capecitabine are tablets. You have bevacizumab as a drip into a vein. You have treatment in cycles.

In the S 95005 and bevacizumab group, each 4 week period (28 days) is called a cycle of treatment.

In the capecitabine and bevacizumab group each 3 week period (21 days) is called a cycle of treatment.

The first day of each cycle is called day 1.

S 95005 and bevacizumab
You have

S 95005 tablets twice a day on days 1 to 5 and 8 to 12
bevacizumab on day 1 and day 15

Capecitabine and bevacizumab
You have

capecitabine tablets twice a day every day for the first 2 weeks of each treatment cycle
bevacizumab on day 1

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

Tissue samples
The doctors need to know if your bowel cancer cells have a RAS gene change. If they do not have this information you might need to give a tissue sample (biopsy Open a glossary item ) of your cancer before you start treatment.

Blood samples
You have 2 extra blood tests as part of this study. Where possible you have these at the same time as your routine blood tests. The researchers want to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others.

Quality of life
The study team ask everybody taking part to complete some questionnaires before treatment starts and then every 3 months during treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.

Hospital visits

You see the study doctors and have some tests before you start treatment. These include

A physical examination
Blood and urine tests
Heart trace (ECG )
CT or MRI scan

You go to hospital to have bevacizumab. You shouldn’t need to stay overnight.

You see the doctors and have some blood tests during the study. This is so they can see how you are getting on. You have a CT scan every 8 weeks.

Follow up

You stop the treatment in the study if your cancer gets worse. Your doctor will talk to you about other treatment options. The study team will continue to see how you are getting on every 2 months. This might be at a routine hospital appointment or they might phone you.

If you stop having treatment but your cancer hasn’t got worse, you have a CT scan every 2 months. You see the doctors until your cancer gets worse or you start another anti cancer treatment.

Side effects

As S 95005 is a new drug, there might be side effects that we don’t know about yet. The study team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.

The most common side effects of S 95005 are

diarrhoea
loss of appetite
tiredness (fatigue)
a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
blood infections
skin infections
feeling or being sick

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