
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called dalotuzumab alongside irinotecan for cancer of the back passage (rectum) that has spread to other parts of the body.
If rectal cancer spreads to another part of the body, you may have a chemotherapy drug called irinotecan and a drug called cetuximab. Cetuximab is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.
In this trial, researchers are looking at another monoclonal antibody called dalotuzumab. Everybody taking part has irinotecan. Some people have cetuximab with it, some have dalotuzumab.
Some bowel cancers have a change (a ) to a gene called K-RAS. We know from research that cetuximab doesn't help people who have this mutation, so the researchers need to test for this.
Before you can take part in this trial, they will ask your permission to get a sample of your cancer that was removed when you had surgery or a . They will test this in the laboratory to see if it has a normal K-RAS gene. They will also measure the levels of 2 markers called IGF-1 and IGF-2. You can only take part in this trial if you have high levels of IGF-1, low levels of IGF-2 and a normal K-RAS gene.
The aim of the trial is to see if the combination of irinotecan and dalotuzumab helps people with rectal cancer more than irinotecan and cetuximab.
You may be able to enter this trial if
You cannot enter this trial if you
This phase 2 trial will recruit about 70 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. You will be told which group you are in, but neither you nor your doctor will be able to decide which group you are in.
You have treatment in 6 week cycles.
You have these drugs through a drip into a vein. As long as you don’t have any bad side effects, you can carry on having the treatment for as long as it helps you.
You see the trial team and have some tests before you start treatment. The tests include
During the trial treatment, you go to hospital once a week. You have regular blood tests and you have a CT scan every 6 weeks.
People having dalotuzumab have another hearing test during the first cycle of treatment to check for any signs of hearing loss.
When you finish treatment, you see the trial team, and have more blood tests and a CT scan. You see the trial team again 2 weeks and 4 weeks later. They will examine you and ask about any symptoms you have and any side effects from the treatment. You also have more blood tests.
They will ask if a nurse can phone you every 3 months to see how you are. This follow up is optional – you don’t have to agree to this if you don’t want to.
As dalotuzumab is a new drug, there may be side effects we don’t know about yet. In earlier trials, when people had dalotuzumab on its own, the side effects included
When people had dalotuzumab at the same time as chemotherapy, the side effects included
We have more information about the side effects of irinotecan and cetuximab.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr David Watkins
Experimental Cancer Medicine Centre (ECMC)
Merck
Sharp & Dohme
National Institute for Health Research Cancer Research Network (NCRN)
Freephone 0808 800 4040
Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.