A trial of Reolysin with chemotherapy for head and neck cancer that has spread to other parts of the body or has got worse despite having other treatment (REO 18)

This trial is looking at having a treatment called Reolysin with paclitaxel and carboplatin chemotherapy for squamous cell cancer of the head and neck. It is for people whose cancer has spread to other parts of the body or has got worse during or after chemotherapy with a platinum drug.

Squamous cells are the flat, skin like cells that cover the inside of the mouth, nose, larynx and throat. If a cancer starts in these cells, it is called a squamous cell carcinoma. Many head and neck cancers are squamous cell carcinomas. Doctors can treat these cancers with radiotherapy, surgery and chemotherapy.

Cisplatin and carboplatin are 2 chemotherapy drugs that doctors often use. They are called platinum drugs. You often have one of these drugs alongside either 5-FU or a taxane drug such as paclitaxel. But sometimes cancer does not respond to this treatment, or it comes back later on. If this happens, you may have more chemotherapy.

Reolysin is a new type of treatment that uses a virus called ‘reovirus’. This common virus rarely causes any symptoms. We know from research that it can kill cancer cells, but does not seem to affect normal cells. Having Reolysin with chemotherapy may help people with head and neck cancer.

The people taking part in this trial have already had chemotherapy that included a platinum drug, but their cancer has come back or spread to other parts of the body. The aim of the trial is to see if having Reolysin at the same time as carboplatin and paclitaxel helps these people more than having the chemotherapy alone.

Recruitment

Start 01/06/2010

End 30/06/2012

Phase

Phase 3

Who can enter

You can enter this trial if you

Have squamous cell carcinoma (SCC) of the mouth or oropharynx, larynx, hypopharynx or nasopharynx that has spread to another part of your body
Have at least one area of cancer that can be measured on a CT scan or MRI scan
Have cancer that got worse within about 6 months of finishing chemotherapy with a platinum drug
Have recovered from the side effects of any other cancer treatment (apart from hair loss)
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood test results
Are willing to use a reliable form of contraception during the trial if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain
Are having any other experimental treatment as part of another clinical trial
Have had chemotherapy, radiotherapy, immunotherapy or hormone therapy in the last 4 weeks
Have had surgery (apart from biopsies) in the last 4 weeks
Have already had a taxane drug for squamous cell carcinoma of the head and neck
Are taking drugs that suppress your immune system (immunosuppressants)
Have had a heart attack in the last year or have other heart problems that are a cause for concern
Have any other medical condition that the trial doctors think could affect your taking part
Are known to be HIV positive or have hepatitis B or C
Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit about 280 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. You will not know which group you are in either. This is called a double blind trial.

Everybody taking part has treatment in 21 day (3 week) cycles of treatment.

People in group 1 have paclitaxel, carboplatin and Reolysin on day 1 of each cycle. You have treatment through a drip into a vein, which takes about 4 and a half hours. On days 2, 3, 4 and 5 you have Reolysin alone, which takes about an hour.

People in group 2 have paclitaxel and carboplatin in the same way, but instead of Reolysin, they have a dummy drug (placebo).

Before you have paclitaxel, you have some other medication to reduce the risk of having a reaction to the drug. And you have medicine for 5 days to prevent flu like symptoms such as fever, chills and headache.

The number of cycles you have will depend on how well the treatment is working. You can have up to 8 cycles of treatment with all 3 drugs. But if your cancer has not got worse, you may continue to have Reolysin (or placebo) for as long as your doctor thinks it is helping you.

The trial doctors may ask your permission to take a sample of your cancer (a biopsy). If you agree to this, you will have a biopsy before your treatment and another after at least 2 cycles of treatment. This will help researchers to study the effects of the virus. You don’t have to have these biopsies if you don’t want to. You can still take part in the trial.

Hospital visits

Before you start the trial, you will see the doctor and have some tests. These tests include

Physical examination
CT scan or MRI scan
Heart trace (ECG)
X-rays
Blood and urine tests

You go to hospital for treatment on the first 5 days of each treatment cycle. You do not have to stay in hospital overnight, but you do have to stay for at least an hour after each infusion of Reolysin (or placebo) so that the doctors can monitor you closely.

On about day 8 of each cycle, a member of the study team will phone you to see how you are. They will ask about any side effects you have noticed and any medication you are taking. If they are concerned about anything, they may ask you to come to hospital for an appointment. You have a CT scan every 6 weeks.

After you finish treatment, you will have another scan and an ECG. You will see the trial doctor a month later and then every 3 months. At these visits the doctor will examine you and you may have blood tests and CT scan.

Side effects

As Reolysin is a new drug, there may be some side effects that doctors don’t know about yet. In earlier trials, side effects have included

Fever and chills
Headache
Tiredness (fatigue)
Runny nose
Cough
Feeling or being sick
Diarrhoea
A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness or shortness of breath
Loss of appetite
Temporary changes in liver function tests