
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is studying a treatment called Reolysin alongside 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 despite previous chemotherapy with a platinum drug.
Squamous cells are the flat, skin like cells that cover the inside of the mouth, nose, larynx and throat. When a cancer starts in these cells, it is called a . Many head and neck cancers are squamous cell carcinomas. Doctors can treat these cancers with radiotherapy, surgery and chemotherapy depending on the extent of the cancer.
Cisplatin and carboplatin are 2 chemotherapy drugs that doctors often use. They are called . You often have one of these drugs alongside drugs such as 5-FU or a
. Paclitaxel is a taxane drug. If the cancer does not respond to the first treatments, or if it comes back later, you may have more treatment, including chemotherapy.
Reolysin is a new type of treatment that uses a called ‘reovirus’. Reovirus is very common in the environment and rarely causes illness. We know from research that it can kill cancer cells, but it 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 is more helpful than having chemotherapy alone.
You can enter this trial if you
You cannot enter this trial if you
This phase 3 trial has recruited 167 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor can 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 to 5 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 ().
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 reduce or prevent flu like symptoms such as fever, chills and headache.
The number of cycles you have depends on how well the treatment is working. You can have up to 8 cycles of treatment with all 3 drugs. If the cancer does not get any 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 ). 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.
Before you start the trial, you will see the doctor and have some tests. These tests include
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 hospital staff 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 problems you have noticed and any medication you are taking. If they are concerned about anything, they may ask you to come to hospital for a check up. You have a CT or MRI 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 a scan.
Reolysin is a new drug, so there may be some side effects that doctors don’t know about yet. In earlier trials, side effects have included
The most common side effects of carboplatin and paclitaxel include
We have more information about carboplatin and paclitaxel 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 Kevin Harrington
Experimental Cancer Medicine Centre (ECMC)
Oncolytics Biotech Inc.
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”