A trial of AZD2014 and paclitaxel for women with ovarian cancer that has come back (OCTOPUS)

Cancer type:

Ovarian cancer

Status:

Open

Phase:

Phase 2

This trial is looking at a new drug called AZD2014 and weekly paclitaxel chemotherapy for ovarian cancer that has come back. It is for women who have

These cancers are treated in a similar way. When we use the term ovarian cancer in this summary, we are referring to all 3. This trial is supported by Cancer Research UK

More about this trial

Doctors usually treat ovarian cancer with surgery followed by chemotherapy. The chemotherapy often includes a platinum drug Open a glossary item such as carboplatin. If your cancer gets worse within 6 months of having this treatment, it is called platinum resistant. You may then have treatment with a taxane Open a glossary item chemotherapy drug called paclitaxel. But sometimes the cancer starts to grow again. So researchers are looking at ways to delay this.

In this trial, they are looking at AZD2014. It is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. 

Doctors know from research that having paclitaxel and AZD2014 together may control the cancer for longer. But they want to find out more. In this trial, everyone has paclitaxel and some people have AZD2014. 

The aims of the trial are to 

  • Find out if adding AZD2014 to weekly paclitaxel is a useful treatment for ovarian cancer
  • Learn more about the side effects
  • Find out how it affects quality of life

Who can enter

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

You may be able to join this trial if all of the following apply. 

  • A tissue sample (biopsy Open a glossary item) taken shows you have ovarian cancer, fallopian tube cancer or primary peritoneal cancer that is high grade serous
  • Your cancer did not respond to platinum chemotherapy Open a glossary item or continued to grow within 6 months of having this treatment (it is platinum resistant or platinum refractory)
  • Your cancer can be seen on a scan
  • The trial team can test a sample of tissue (biopsy Open a glossary item) that was removed when you had your ovarian cancer surgery or you are willing to have a sample of tissue taken
  • You are willing to have a further tissue sample taken before you start treatment
  • You are well enough to take part (performance status 0 or 1)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance that you could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have cancer has spread to your spinal cord Open a glossary item or brain unless it has been treated, you have no symptoms and your condition has been stable for at least 4 weeks
  • Have a tumour that isn’t high grade serous
  • Have already had weekly paclitaxel for platinum resistant ovarian cancer
  • Have had any cancer treatment including experimental drugs in the 2 weeks before joining the trial
  • Are having medication called warfarin to thin your blood. You may take part if you are having another blood thinning medication called heparin
  • Are having growth factors such as G-CSF or GM-CSF Open a glossary item or you have a blood transfusion within 2 weeks of starting trial treatment
  • Have a condition called interstial lung disease
  • Have a problem with your liver or kidneys
  • Have a serious heart problem
  • Have had an abnormal heart rhythm called torsades de pointes in the last year
  • Have high blood pressure that isn’t well controlled with medication
  • Have problems with bleeding
  • Have had a severe allergic reaction to paclitaxel in the past
  • Have an active hepatitis B or C infection or you are HIV positive
  • Have any side effects from previous treatment that haven’t resolved apart from hair loss
  • Have had major surgery in the last month or minor surgery in the last 2 weeks
  • Have recently had a blood clot in your leg (a deep vein thrombosis) or a blood clot in your lung (a pulmonary embolism)
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 140 women to join. 

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. And neither of you will know which group you are in. This is called a double blind trial.

  • One group have weekly paclitaxel and AZD2014
  • The other group have weekly paclitaxel and a dummy drug (placebo Open a glossary item)

Diagram for OCTOPUS

You have paclitaxel as a drip into a vein. You have treatment once every week for 3 weeks and then a week without treatment. It takes about an hour each time. You have paclitaxel for about 6 months. You may have treatment for longer if it is helping. Your doctor will tell you more if this applies. 

AZD2014 and the dummy drug are tablets. You take AZD2014 or the dummy tablets twice everyday for 3 days each week. You start taking the tablets on the same day you have paclitaxel. You have them for 3 weeks and then you have a week without treatment. 

When you finish chemotherapy, your doctor may decide that you can continue with the tablets. This is called maintenance treatment. You have the tablets every day. You continue having them as long as it is helping you and the side effects aren’t too bad.

Quality of life
The trial team will ask you to fill out a questionnaire before you start treatment and at set times during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is a quality of life study. 

Research samples
You have extra blood tests as part of this trial. Where possible you have these at the same time as your routine blood tests. The researchers want to look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others. They are also looking for changes in genes (mutations Open a glossary item) that may have been passed down by your parents.

The researchers may also ask to take biopsies of your cancer at the beginning and during treatment. They will look for biomarkers and they may use the sample for other tests in the future.

If you don’t want to give these samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These include

  • Blood tests
  • Urine tests
  • A heart trace (electrocardiogram Open a glossary item)
  • Heart scan (Echocardiogram Open a glossary item or MUGA Open a glossary item)
  • CT scan or MRI scan

You have your chemotherapy at the hospital. 

If you continue with the maintenance part of the trial you go to the hospital once a month for a check up until you stop treatment.

When you finish treatment the trial team will follow you up every month to see how you are getting on. You have a CT scan or a MRI scan every 2 months.

Side effects

AZD2014 is a new drug and there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you will be given a phone number to call them if you are worried about anything.

The most common side effects of AZD2014 so far include

It is possible that taking AZD2014 can make you more sensitive to sunlight. You should avoid going out in the sun for long periods during treatment and for 3 months afterwards. You should use adequate sun protection and avoid using sunbeds or tanning booths.

We have information about paclitaxel.

Location

Bath
Brighton
Bristol
Dundee
Edinburgh
Glasgow
Leeds
London
Manchester
Northwood
Nottingham
Oxford
Reading
Southampton
Sutton
Taunton

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

Dr Susana Banerjee

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
University of Glasgow
NHS Greater Glasgow and Clyde

Other information

This is Cancer Research UK trial number CRUKE/14/052.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12661

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

Rate this page:

Currently rated: 5 out of 5 based on 1 vote
Thank you!
We've recently made some changes to the site, tell us what you think