A trial of enadenotucirev for ovarian cancer (OCTAVE)

Cancer type:

Ovarian cancer

Status:

Open

Phase:

Phase 1/2

This trial is for women with ovarian cancer that has got worse despite having platinum chemotherapy. Platinum chemotherapy Open a glossary item includes the drugs cisplatin, carboplatin and oxaliplatin.

It is for women who have 1 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

When ovarian cancer can’t be removed with surgery, doctors usually treat it with chemotherapy that includes a platinum drug such as:

But sometimes the cancer starts growing again within a few months of having this type of treatment. So researchers are looking for new treatments to help women in this situation. In this trial, they are looking at a drug called enadenotucirev (previously known as EnAd or ColoAd1).

Enadenotucirev is a virus that has been made to kill cancer cells but not affect normal cells. You have this drug either into your bloodstream (intravenously) or directly into your tummy (abdomen) Open a glossary item. This is called intraperitoneal treatment.

The first few women joining this trial had enadenotucirev alone. This part of the trial is now closed. Women joining now also have a chemotherapy drug called paclitaxel (Taxol).

The main aims of the trial are to:

  • find the best dose of enadenotucirev that you can have both on its own and alongside paclitaxel
  • learn more about the side effects
  • find out more about what happens to enadenotucirev in your body
  • see if the combination of enadenotucirev and paclitaxel helps women with ovarian cancer

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

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 or 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
  • You have cancer that is sticking to other organs in your abdomen, or affecting the top part of bowel (your small bowel)
  • You have certain rare types of ovarian cancer (the trial team can advise you about this)
  • You have had another experimental drug in the last 4 weeks 
  • You have had major surgery in the last 2 weeks
  • You are currently having any other anti cancer treatment
  • You have had any other cancer in the last 3 years apart from carcinoma in situ of the cervix  or non melanoma skin cancer
  • You have a blockage in your bowel (bowel obstruction) that is causing symptoms such as bloating, sickness, constipation or diarrhoea
  • You have a condition that causes inflammation Open a glossary item of your bowel
  • You 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)
  • You have had your spleen Open a glossary item removed
  • You have had an organ transplant, a bone marrow transplant or a stem cell transplant 
  • You have an active infection that causes high temperatures or needs antibiotics
  • You have an infection caused by a virus or take certain anti viral medication (the trial team can advise you about this)
  • You have certain heart problems (the trial team can advise you about this)
  • You have any other medical condition or mental health problem that the trial team think could affect your taking part
  • You are known to be allergic to the drugs in this trial, or anything they contain
  • You are HIV, hepatitis B or hepatitis C positive
  • You are pregnant or breastfeeding

Trial design

This trial is in 2 parts. The researchers need up to 36 women to take part in part 1 and up to 23 women to join part 2. Everybody taking part has enadenotucirev.

Part 1
In this part, researchers want to find the highest dose of enadenotucirev that you can have safely alongside paclitaxel. 

The first few women have a low dose of enadenotucirev. If they don’t have any serious side effects, the next few have a higher dose. This continues, until doctors find the best dose. This is called a dose escalation study.

You can have enadenotucirev either as:

Your doctor will tell you how you’ll have enadenotucirev. It depends on when you join the trial.   
 
If you have enadenotucirev into your tummy, you have a small flexible tube called an intraperitoneal catheter. The catheter is put in under local anaesthetic a week before you start treatment. If you already have an intraperitoneal catheter, the trial team might be able to use this.

To have enadenotucirev, you lie down with the head of the bed raised up slightly. The trial team inject some fluid into your abdomen, then the enadenotucirev, 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 enadenotucirev evenly.

You have enadenotucirev 6 times in total. Your doctor can tell you when you have it. 

You also have paclitaxel through a drip into a vein once a week, for 6 weeks. You have it on a different day to the enadenotucirev.  

Part 2
In part 2, researchers want to see how much the treatment helps women with ovarian cancer. 

Everybody joining this part has enadenotucirev and paclitaxel. 

You have the highest safe dose of enadenotucirev that was found in part 1 and paclitaxel at the usual dose.

You have both drugs into your bloodstream (intravenously). 

Blood tests 
You have some extra blood tests as part of this trial. The researchers want to find out what happens to enadenotucirev in your body and look for certain proteins (cytokines) made by your immune system Open a glossary item

You have the extra blood samples before the start of treatment and then:

  • at set times during the trial
  • a month after the last treatment 

Tissue samples
You need to give a tissue sample of your cancer before you start treatment. Researchers will ask to use a sample of your cancer taken either when you were diagnosed or during other treatments. 

The trial team will also ask you to have a new tissue sample (a biopsy Open a glossary item) about 33 days after starting treatment. They want to look at your cancer and at the amount of enadenotucirev in the cancer cells.  

You might also have extra biopsies after you finish treatment. Your doctor can tell you how often you have them. You do not have to agree to have tissue samples taken after treatment if you don’t want to. You can still take part in this trial.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include:

When you have your 1st dose of enadenotucirev, you stay in hospital for at least 12 hours afterwards. As long as you don’t have a bad reaction, you may be able to go home sooner after your other doses. But if you have a bad reaction to enadenotucirev, you will have to stay in hospital until any symptoms get better.

You go to hospital to have treatment about 12 times. You see the trial doctor and have regular blood tests and urine tests each time.

After you finish treatment, you see the trial doctor after 1 and 2 months. Then you see the trial doctor every 2 months. You have blood tests and a physical examination at these visits. 

You also have a CT or MRI scan every 2 months. This continues for at least 6 months.

Side effects

The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything.  The team will tell you about all the possible side effects before you start the trial.

Enadenotucirev is a new treatment and there might be side effects we don’t know about yet. In trials so far, the most common side effects of enadenotucirev have included:

You must avoid close physical contact with anybody in the following groups for the duration of the enadenotucirev 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

The most common side effects of paclitaxel are:

  • a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • flushing or skin rash
  • feeling or being sick
  • diarrhoea
  • 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)

We have more information about paclitaxel.

Location

Glasgow
Guildford
Manchester

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Iain McNeish

Supported by

NIHR Clinical Research Network: Cancer
PsiOxus Therapeutics Ltd

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11596

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

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“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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