"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of EnAd for ovarian cancer (OCTAVE)
This trial is looking at a drug called EnAd (also known as ColoAd1) that you have directly into your tummy (abdomen). It is for ovarian cancer that has got worse despite having platinum chemotherapy.
The trial is for women who have one of the following
These cancers are treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all of these.
More about this trial
If ovarian cancer can’t be removed with surgery, doctors usually treat it with chemotherapy that includes a
EnAd consists of part of a virus that has been made to kill cancer cells but not affect normal cells. You have it directly into your tummy (
The first few women joining this trial have EnAd alone. Women joining later also have a chemotherapy drug called paclitaxel through a drip into a vein.
The aims of the trial are to
- Find the best dose of EnAd that you can have directly into your abdomen, both on its own and alongside paclitaxel
- Learn more about the side effects
- Find out more about what happens to EnAd in your body
- See if the combination of EnAd and paclitaxel helps women with ovarian cancer
Who can enter
You may be able to join this trial if all of the following apply
- You have ovarian cancer, primary peritoneal cancer or fallopian tube cancer that can’t be removed with surgery
- Your cancer has got worse within 6 months after having completed chemotherapy with a
platinum drug(this does not need to be your most recent cancer treatment before you join this trial). You may be able to join the first part of the trial if you aren't in this situation, but there are no other treatments available for you
- You have recovered from the side effects of any other cancer treatment unless they are very mild (apart from hair loss)
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use 2 forms of reliable contraception during the trial and for 3 months afterwards if there is any chance you could become pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have cancer that has spread to your brain or spinal cord (your central nervous system) and is causing symptoms
- Have cancer that is sticking to other organs in your abdomen, or affecting the top part of bowel (your small bowel)
- Have certain rare types of ovarian cancer (the trial team can advise you about this)
- Have had another experimental drug in the last 4 weeks
- Have had major surgery in the last 2 weeks
- Are currently having any other anti cancer treatment
- Have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix or non melanoma skin cancer
- Have a blockage in your bowel (bowel obstruction) that is causing symptoms such as bloating, sickness, constipation or diarrhoea
- Have a condition that causes
inflammationof your bowel
- Have problems with your immune system due to another condition, or because you take medication that can damp it down, such as steroids. You may be able to take part if you have been taking a low dose of steroids, or a higher dose for less than 2 weeks (the trial team can confirm this)
- Have had your
- Have had an organ transplant, a bone marrow transplant or a stem cell transplant
- Have an active infection that causes high temperatures or needs antibiotics
- Have an infection caused by a virus or take certain anti viral medication (the trial team can advise you about this)
- Have certain heart problems (the trial team can advise you about this)
- Have any other medical condition or mental health problem that the trial team think could affect your taking part
- Are known to be allergic to the drugs in this trial, or anything they contain
- Are HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
This trial is in 2 parts. The researchers need up to 47 women to take part. Everybody taking part will have EnAd.
In the 1st part of the trial, the researchers want to find the highest dose of EnAd that you can have safely, both on its own and alongside paclitaxel. The first few patients taking part will have a low dose of EnAd. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.
To begin with, women joining this part of the trial will have EnAd alone. But women joining this part of the trial a bit later will also have paclitaxel.
In the 2nd part of the trial, the researchers want to see how much the treatment helps women with ovarian cancer. Everybody joining this part of the study will have EnAd and paclitaxel. They will have the highest safe dose of EnAd that was found in the 1st part of the trial and paclitaxel at the usual dose that is used when you have it once a week.
You have EnAd directly into your tummy (
You have EnAd 6 times in total. You have the first 3 doses once a week for 3 weeks. You then have a week without treatment, before having the next 3 doses once a week for 3 weeks.
To have the EnAd, you lie down with the head of the bed raised up slightly. The trial team will inject some fluid into your abdomen, then the EnAd, followed by some more fluid. It takes about 1½ hours in total.
The nurse or doctor looking after you will ask you to roll from side to side every so often during the treatment. This helps to spread the EnAd evenly.
If you have paclitaxel, you have this through a drip into a vein once a week for 6 weeks. You have it on a different day to the EnAd.
You see the trial team and have some tests before you start treatment. The tests include
The trial team will ask your permission to get a sample of your cancer that was removed when you had surgery or a
Before you have your 1st treatment, the trial team will ask you for a urine sample. And they will take swabs from your mouth and from your
The trial team will talk to you about how often you will need to go to hospital. When you have your 1st dose of EnAd, you stay in hospital for at least 24 hours afterwards. As long as you don’t have a bad reaction, you may be able to go home 8 or 9 hours after your other doses. But if you have a bad reaction to EnAd, you will have to stay in hospital until any symptoms get better.
If you have EnAd alone, you go to hospital for treatment up to 6 times. If you have EnAd and paclitaxel, you go to hospital 12 times. You have regular blood tests and urine tests. Before each EnAd treatment, the trial team will take a sample of fluid from your abdomen through the intraperitoneal catheter.
If you are in the 1st part of the trial and have EnAd alone, after your last dose of EnAd you will see the trial team again each week for the next 3 weeks. You will have a physical examination, blood tests and urine tests. The first time you go to hospital after your last dose of EnAd, the trial team will also take swabs from your mouth and back passage (your rectum). This is to see whether the virus is shed from the body and if so, how much and for how long.
If you are in the 1st part of the trial and have EnAD and paclitaxel, or you are in the 2nd part of the trial, you see the trial team 3 weeks after your last dose of paclitaxel to have a physical examination, blood tests and urine tests. The trial team will also take swabs from your mouth and rectum.
After these visits, you go back to see the trial team every 8 weeks for at least 6 months. You may have a CT or MRI at these visits.
The most common side effects of paclitaxel include
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Flushing or skin rash
- Feeling or being sick
- Inflammation of the lining of your mouth, throat, and other parts of your body (your mucous membranes)
- Hair loss
- Low blood pressure
- Muscle and joint pain
- Numbness and tingling in your hands and feet (peripheral neuropathy)
As EnAd is a new treatment, there may be side effects we don’t know about yet. Your trial doctor will discuss the common side effects with you.
In trials so far, side effects have included
- High temperature (fever) possibly with chills and shivers
- Other flu like symptoms such as tiredness, body aches and loss of appetite
- Feeling or being sick
- A change to the way your liver works
- A drop in blood cells causing an increased risk of infection and bleeding problems
- Swelling of your cancer when the virus gets into the cells
- Inflammation of the bladder (you may need to pass urine more often, passing urine may be painful and there may be blood in your urine)
Having an intraperitoneal catheter can cause infection, pain and damage to your bowel. It is possible that the catheter may stop working and need to be removed. If this happens, it may be possible to replace it or the treatment directly into your tummy will stop.
When you have fluid or the drug through the catheter, you may have some temporary pain, bloating or discomfort and you may feel sick. Rolling from side to side during the treatment may be uncomfortable.
You must avoid close physical contact with anybody in the following groups for the duration of the EnAd treatment and for 4 weeks afterwards.
- Women who are pregnant or breastfeeding
- Children under a year old
- Someone who has problems with their immune system either due to a medical condition or because they take drugs that damp it down, such as steroids
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Iain McNeish
NIHR Clinical Research Network: Cancer
PsiOxus Therapeutics Ltd