A trial looking at E7050 for head and neck cancer

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

Cancer type:

Head and neck cancers

Laryngeal cancer

Mouth (oral) cancer

Nasal and paranasal sinus cancer

Status:

Closed

Phase:

Phase 1/2

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 squamous cell cancer Open a glossary item .

Doctors treat these cancers with a platinum chemotherapy drug Open a glossary item 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 laboratory studies Open a glossary item . 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

The best dose of E7050 to give
How well the combination of E7050 and cetuximab works
What the side effects are

Who can enter

You may be able to enter this trial if you

Have squamous cell cancer of the larynx, mouth and oropharynx, or nose and sinuses
Have cancer that has grown into the surrounding tissues (is locally advanced) or has spread to another part of your body
Have cancer that continued to grow during treatment with a platinum chemotherapy drug, such as carboplatin or cisplatin or your cancer came back within a year of having this treatment
Have cancer that can’t be treated with radiotherapy or be removed with surgery
Have one area of cancer that can be measured on a scan
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood tests results
Are willing to use 2 reliable forms of contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have nasopharyngeal cancer
Have cancer that has spread to your brain – if this was successfully treated more than a month ago, you have no symptoms and you have not had steroids in the past month you may be able to take part
Have already had E7050 or any similar drugs – your doctor can confirm this
Still have side effects from any anti cancer treatment you’ve had in the past month, apart from some hair thinning
Have severe nerve damage
Might need to have radiotherapy for symptoms during the study
Have had another cancer apart from successfully treated non melanoma skin cancer, or successfully treated in situ carcinoma of the cervix, prostate cancer, superficial bladder cancer or any other solid tumour that was successfully treated and there has been no sign of it in the past 3 years
Have had major surgery in the past month
Have had a serious wound that hasn’t healed, an ulcer or bone fracture in the past month
Have had bleeding varicose veins
Have any other problems with bleeding – if this is due to blood thinning medication you may be able to take part
Have coughed up ½ a teaspoon or more of bright red blood in the past month
Have had any serious problems with bleeding in your digestive system in the past 6 months
Have had a blood clot (deep vein thrombosis – DVT) in the past 6 months that hasn’t been treated
Have had a blood clot of the vein that goes into your liver (hepatic portal vein)
Have problems with your digestive system that could affect you taking tablets
Have had a heart attack in the past 6 months or any other serious heart problem
Have had an organ transplant and need to take medication to damp down your immune system
Are known to have HIV, hepatitis B or hepatitis C
Have any other condition that could affect you taking part in this trial
Are pregnant or breastfeeding

Trial design

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 and cetuximab
Cetuximab

E7050 for head and neck cancer trial diagram

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 biopsy Open a glossary item ) from your cancer. They will use this to look for substances (biomarkers ) 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.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

A physical examination
Blood tests
Urine test
CT scan or MRI scan
Heart trace (ECG )

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.