
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a drug called olaparib for women who have ovarian cancer, fallopian tube cancer or primary peritoneal cancer with a change to a gene called BRCA1 or BCRA2.
Ovarian cancer, fallopian tube cancer and primary peritoneal cancer are all treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all 3.
If ovarian cancer has grown outside the area between your hips (your pelvis), or spread to another part of your body when it is diagnosed, it isn’t possible to remove it completely with surgery. You may have surgery to remove as much of the cancer as possible, but doctors would usually recommend that you also have chemotherapy.
The women taking part in this trial have already had chemotherapy and their cancer responded to the treatment. In this situation, you wouldn’t usually have any other treatment unless your cancer comes back or starts to grow again. But researchers want to see if taking a drug called olaparib after chemotherapy helps stop the cancer coming back as quickly.
Olaparib is a type of biological therapy called a PARP-1 inhibitor. This means it blocks an called PARP-1, which helps damaged cells to repair themselves.
The cells in your cancer already have problems repairing cell damage, because of the BRCA gene fault. Doctors hope that if they can also stop PARP-1 working, the cancer cells will not be able to repair themselves and will die.
The aim of the study is to see if taking olaparib after chemotherapy helps women with ovarian cancer, and delays the cancer coming back or starting to grow again.
You may be able to enter this trial if you
To be able to take part in this trial, the researchers need a sample of your cancer that was taken when you had surgery or a biopsy. If there isn’t a sample available, you won’t be able to take part.
As well as the above, if your cancer is stage 3, you must have had surgery to try to remove as much of the cancer as possible. This is called debulking. If your cancer is stage 4, you must have had either a biopsy or debulking surgery.
You cannot enter this trial if you
This phase 3 trial will recruit more than 300 women in a number of different countries. It is a randomised trial. The women 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.
Women in one group take olaparib tablets twice every day. Women in the other group take dummy tablets ().
There will be twice as many women in the group taking olaparib as in the group taking the dummy drug.
As long as you don’t have bad side effects, and the trial tablets appear to be helping, you can carry on taking them for up to 2 years. If your cancer hasn’t got worse, the trial doctor may talk to you about taking the tablets for longer than 2 years. But if your cancer has disappeared completely after 2 years, you will stop the trial treatment.
The trial team will ask you to fill out a questionnaire before you start treatment, every 4 weeks during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the trial team and have some tests before you start the trial treatment. The tests include
The trial team will ask if you would be willing to have another at this time and a further biopsy if your cancer gets worse. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
You see the trial team once a week for 4 weeks and then every 4 weeks until you stop the trial treatment.
You have a CT or MRI scan every 3 months during treatment for up to 2 years. If you carry on having the trial treatment for longer than 2 years, you then have a scan every 6 months.
When you finish treatment, you see the trial team again about a month later. They will then contact you by phone every 3 months to see how you are.
Also, if you stop the trial treatment for any reason other than your cancer growing, the trial team will ask you to see them and have a scan every 3 months until your cancer does start to get worse.
All medicines have side effects. As olaparib is new drug, we are still learning about the side effects through . Your doctor will discuss the possible side effects with you before you agree to enter the trial. And throughout the trial, your doctor will ask how you are feeling.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Charlie Gourley
AstraZeneca
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.