A trial of different treatments for women who have ovarian cancer (OCTOVA)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Ovarian cancer

Status:

Closed

Phase:

Phase 2

This trial is for women whose platinum chemotherapy has stopped working.

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.

Cancer Research UK supports this trial.

More about this trial

Surgery and platinum chemotherapy such as cisplatin and carboplatin are the usual treatments for ovarian cancer. But sometimes treatment stops working. So then you usually have standard treatment if this happens. A treatment commonly used is a chemotherapy drug called paclitaxel. But it might be possible to treat these cancers with other drugs.

In this study, doctors are looking at 2 drugs called olaparib and cediranib. Both drugs are targeted treatments (or biological therapies) that work in different ways.

Olaparib is a PARP inhibitor. PARP is a protein that helps cells to repair. The researchers hope that by stopping PARP from working, cancer cells won’t be able to repair themselves and will die.

Cediranib is tyrosine kinase inhibitor. It stops cancers from being able to make new blood vessels that they need to grow. We know from research that having it with olaparib helps control the cancer for longer.

The aims of the study are to:

find out how well olaparib works compared to paclitaxel
find out if olaparib and cediranib works better than olaparib
find out if the targeted treatments cause fewer side effects and improve quality of life due to having fewer hospital treatment visits

Who can enter

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

You might be able to join this study if all of the following apply.

You have ovarian cancer, fallopian tube cancer or primary peritoneal cancer and your cancer got worse within 12 months of having platinum chemotherapy
You have cancer that can be measured on scan and you had a scan in the last 4 weeks
There is a tissue sample (a biopsy) available for the study team to do some tests
You can swallow tablets
You are well enough to be up and about for at least half the day (performance status 0,1 or 2)
You have satisfactory blood and urine 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 16 years old

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

Cancer related

Have cancer that has spread to your brain or tissues surrounding the brain and is causing symptoms - you might be able to take part if the cancer spread to your brain was treated, is stable and you aren’t taking steroids or you started taking a stable dose more than 28 days ago
Have had weekly paclitaxel for ovarian cancer that has come back
Have recently (within the last 6 months) had treatment with a PARP inhibitor such as veliparib
Have had drugs that blocks cancer cells growing blood vessels (anti angiogenic treatment) in the last 6 months apart from bevacizumab as long as you had it more than 6 weeks ago
Have had radiotherapy within 2 weeks of joining the study
Have had chemotherapy or treatment as part of a clinical trial in the last 28 days
Started taking bisphosphonates within 4 weeks of joining the study – you might be able to take part if you have had them for longer
Still have moderate to severe side effects from cancer treatment apart from hair loss
Have spinal cord compression unless it was successfully treated and it hasn’t got worse in the last 4 weeks
Have any other active cancer apart from carcinoma insitu of the cervix or non melanoma skin cancer that might need treatment

Medical conditions

Have myelodysplastic syndrome or acute myeloid leukaemia
Have problems with your heart, for example you have had a heart attack, you have high blood pressure that is not well controlled or an abnormal rhythm of your heart
Have a blockage in the large vein that brings blood back to your heart (the superior vena cava)
Have problems with the left side of the heart pumping blood around the body
Have had major surgery within 2 weeks of starting the treatment in this study or you have not fully recovered from surgery
Have an infection that needs treatment
Have severe lung disease in both lungs
Have had a stroke in the last year
Have inflammatory bowel disease
Have had problems with your digestive system in the last 6 months that may interfere with how you absorb the study drug
Have had a major bleed in the last 3 months or vomited a large amount of blood in the last 4 weeks
Have problems with your immune system or take medication that dampens down the immune system
Have HIV
Have hepatitis B or hepatitis C
Have any other serious medical condition or mental health problem that the study team think could affect you taking part

Other

Have had a blood transfusion within 1 month of starting treatment in this study
Are sensitive to cediranib, olaparib, paclitaxel or anything they contain and this means your doctor thinks you can't have the treatment in the trial
Are taking any medication that blocks or induces an enzyme called CYP3A4 such as rifampicin or St John’s Wort
Are pregnant or breastfeeding

Trial design

This phase 2 study is based in the UK. The researchers need 138 women to take part.

It is a randomised study. You are put into 1 of 3 groups. Neither you nor your doctor will be able to decide which group you are in. You have 1 of the following:

paclitaxel
olaparib
olaparib and cediranib

OCTOVA trial diagram

You have paclitaxel as a drip into the vein. The first day of treatment is called day 1. You have it on:

day 1
day 8
day 15

You have treatment in cycles. Each cycle is 4 weeks.

Olaparib and cediranib are tablets you take every day. You take olaparib twice a day and cediranib once a day. The trial team will give you a fresh supply of tablets every 4 weeks on the 1st day of the next treatment cycle.

You have treatment for as long as it is helping you and you can manage any side effects. If you are in the group having paclitaxel and your cancer gets worse, you might be able to have olaparib. Your doctors will speak with you about this if this applies.

You stop treatment if your cancer gets worse. You see the trial team a month later for a final check up. Your doctor will talk to you about other treatment options.

Samples for research
The researchers will ask for samples of your cancer that were removed when you had surgery or a previous biopsy. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to look at:

gene changes (mutations)
substances called biomarkers to help work out why treatment might work for some people and not for others

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

Hospital visits

You see a doctor and have some tests before you can take part. These include:

a physical examination
blood tests
urine tests
heart trace (ECG)
heart scan (echocardiogram)
MRI or CT scan

You see a doctor or research nurse for a checkup and blood tests every

week in the first month
2 weeks in the 2nd and 3rd month of treatment
once a month after that

You have a CT or MRI scan every 2 months. After 18 months of treatment, you go to the hospital less frequently for routine checks up. Your doctor can tell you how often these visits are.