
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 drugs called E7050 and cetuximab (Erbitux) to treat certain cancers of the head and neck. This trial is open to people who have cancer of the mouth and oropharynx, cancer of the larynx or cancer of the nose and sinuses and is of the type called .
Doctors treat these cancers with a such as carboplatin or cisplatin. If the cancer continues to grow or comes back after treatment they then may use a biological therapy drug called cetuximab. Cetuximab works well but doctors are always looking for ways to improve treatment.
E7050 is a new biological therapy drug. It works by blocking a protein on the cancer cell that is involved in making blood vessels. Some cancer cells make too much of this protein. By blocking this protein, we can stop the cancer from growing the blood vessels it needs in order to continue to get bigger.
We know that the combination of E7050 and cetuximab can stop the growth of head and neck cancer cells in . The researchers now want to find out if this combination can help people with cancer of the head and neck.
The aims of this trial are to find out
You may be able to enter this trial if you
You cannot enter this trial if you
This trial is in 2 parts. The first part is a phase 1 trial. This part will recruit 15 people. The first few people will have the lowest dose of E7050. If they don’t have any serious side effects the next few will have a higher dose. And so on, until they find the best dose of E7050 to give. This is called a dose escalation study.
The 2nd part is a phase 2 trial. It will recruit 80 people. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. The 2 treatment groups are
E7050 is a tablet. You take it every day. Cetuximab is a liquid. You have it weekly as an injection into a vein.
You have treatment for 24 weeks if it is helping you and side effects aren’t too bad. After this you may be able to continue with your trial treatment. Your doctor will talk to you about this.
The team will take some blood samples during your treatment. They will use these to see how your body absorbs the drugs, breaks them down and gets rid of them. You must agree to have these blood samples taken if you want to take part in this trial.
They would also like to take some other blood samples. But you don’t have to agree to this if you don’t want to.
On the days when you give blood samples you don’t take your medication and you can’t eat or drink (apart from water) before you see the doctor. For 2 hours after you take your medication you can’t eat and can drink only water.
The researchers will also ask for a piece of tissue taken when you had surgery or a sample of tissue taken (a ) from your cancer. They will use this to look for substances (
) in the body that may show how well you are responding to treatment. If you don’t want to give this tissue sample for this study, you don’t have to. You can still take part in the trial.
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor every week for the same tests apart from the heart trace. You have a CT scan or MRI scan every 2 months for 6 months and then every 3 months.
At the end of treatment you see the doctor for the same tests including the heart trace. You have a CT scan or MRI scan every 3 months until your cancer gets worse or your doctor starts you on another treatment.
E7050 is a new drug and there may be some side effects we don’t know about. The most common side effects reported include
The most common side effects of cetuximab are
We have more information about cetuximab in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Andrew Skyes
Eisai
Experimental Cancer Medicine Centre (ECMC)
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.