A trial looking at zalutumumab for squamous cell carcinoma of the head and neck

Please note this trial is no longer recruiting patients.

This trial is looking at a new monoclonal antibody for head and neck cancer that has grown or come back after chemotherapy with a platinum drug.

Many head and neck cancers are squamous cell carcinomas. Squamous cells are the flat, skin like cells that cover the inside of the mouth, nose and throat. Carcinoma just means cancer. So squamous cell carcinoma is cancer that starts in these cells.

Zalutumumab is a type of biological therapy called a monoclonal antibody. It sticks to a particular protein called the EGF receptor on the surface of cancer cells. When the drug sticks to the cancer cells, it may be able to shrink the tumour, or to stop or slow down its growth. So it is a cancer growth blocker.

In this trial, the researchers want to find out if zalutumumab stops or slows down the growth of squamous cell carcinoma. And see if it can improve quality of life. The aims of the trial are to

See if zalutumumab helps people with head and neck cancer
Learn more about the side effects

Recruitment

Start 01/11/2006

End 10/06/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have squamous cell carcinoma of the larynx, hypopharynx, mouth or oropharynx that your doctors don’t think can be cured with standard treatment
Have had at least one course of chemotherapy including a platinum drug
Have cancer that has got bigger during chemotherapy or has come back within 6 months of finishing treatment
Have satisfactory blood test results
Are well enough to take part (performance status 0, 1 or 2)
Are at least 18 years old
Are willing to use reliable contraception during the trial and for a year afterwards if there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain
Have had more than 3 other types of chemotherapy
Have chemotherapy in the 4 weeks before the first treatment in the trial
Have your cancer completely removed with surgery in the 4 weeks before the first treatment in the trial
Have already had an anti EGFR treatment
Have had another drug as part of a clinical trial in the last 4 weeks
Have had another type of cancer unless it has been in remission for at least 5 years, apart from basal or squamous cell skin cancer, CIS or stage 1A cervical cancer or melanoma skin cancer that was successfully treated and has been in complete remission for at least 10 years
Have an infection
Have heart problems
Have another medical condition that could affect you taking part in this trial
Are known to be HIV, hepatitis B or hepatitis C positive
Are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit up to 273 patients in Europe and Canada. The people taking part are put into one of 2 groups by a computer. Neither you nor your doctor can choose which group you are in.

People in group 1 will have all treatment that is available to help any cancer symptoms and side effects and to improve their quality of life. Researchers usually call this ‘best supportive care’. It can include help with diet problems, antibiotics, steroids and treatment for pain or sickness. Some people may have chemotherapy as part of best supportive care. Your doctor will discuss which treatments are best for you.

People in group 2 will have best supportive care and zalutumumab as a drip into a vein once a week. You can go on having the treatment for as long as it helps you.

Everybody taking part will be asked to fill out a questionnaire at the beginning of the trial and then every 8 weeks. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The doctors will ask your permission to take an extra blood sample at the beginning of the trial. They will look at this to try and learn more about the genes of people who have head and neck cancer. They will also ask to get a sample of the tissue taken when your cancer was first diagnosed, so they can learn more about the type of cancer you have.

If you are in group 2, the trial team will ask if they can take 2 extra biopsies from your cancer. If you agree, they will take one before you start treatment and another 4 weeks later. This is so the researchers can see how the drug is affecting the cancer cells. If you don’t want to give blood or tissue samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

Before you start treatment, you will go to hospital to see the doctors and have some tests including

Physical examination
CT scan or MRI scan
Blood tests

During the treatment, people in group 1 will visit hospital at least once every 4 weeks to see the doctors and have a blood test.

People in group 2 will visit hospital every week to have zalutumumab. Having the drug will take about an hour each time. But you have a blood test first, and you must stay at the hospital for at least 1 or 2 hours afterwards. So each visit will be about 4 hours.

Everybody taking part in the trial will have a CT or MRI scan every 8 weeks.

After you finish treatment, you will have one more hospital visit about 2 weeks later. And people in group 2 will have one more blood test. After that, a member of the trial team will contact you every 4 weeks to see how you are.

Side effects

Side effects of zalutumumab include skin rash, dry or itchy skin, fever, tiredness, sweating, shivering, chills and headache. As this is a new drug, there may be other side effects that we don’t know about yet.

Having a skin rash may show that you are responding to the trial drug. So if you don’t get a skin rash, the doctors will increase the dose of the drug, until you do. They will examine your skin each week. If the rash gets very bad, they may stop the treatment for a while and then start it again at a lower dose when the rash gets better.