Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at rucaparib for ovarian cancer that has responded to platinum chemotherapy (ARIEL3)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at rucaparib (pronounced roo-kap-a-rib) for women whose ovarian cancer has responded to platinum chemotherapy.
The trial is for women with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. These cancers are all treated in the same way, so when we use the term ovarian cancer in this summary, we are referring to all 3.
More about this trial
Ovarian cancer often responds well to chemotherapy that includes a
Researchers are looking for new treatments to help stop ovarian cancer coming back as quickly after you have had chemotherapy. In this trial, they are looking at a drug called rucaparib.
Rucaparib is a type of drug known as a PARP inhibitor. PARP is an enzyme that helps damaged cells to repair themselves. If PARP is blocked, cancer cells may not be able to repair themselves.
The researchers will take blood samples to look for substances (biomarkers) such as
The women taking part in this trial will have had chemotherapy containing a platinum drug at least twice and their cancer responded well each time. The main aim of the trial is to see if taking rucaparib helps women in this situation, and if it delays the cancer coming back again.
The additional aims of this trial are to
- Find out about the benefits of rucaparib for women with ovarian cancer
- Look for biomarkers of ovarian cancer and find out how ovarian cancer with these biomarkers responds to rucaparib
- Find out more about the side effects of rucaparib
Who can enter
You may be able to join this trial if all of the following apply
- You have epithelial ovarian cancer that is
high grade, fallopian tube cancer or primary peritoneal cancer
- Your epithelial ovarian cancer is a type called serous or endometrioid (your doctor can tell you this)
- There is a sample of your cancer from when you had surgery or
biopsythat the researchers can look at (your doctor can tell you this)
- You’ve had chemotherapy at least twice and both times it included a
- Your cancer had got worse or came back at least 6 months after the 2nd to last platinum drug chemotherapy you had. That is to say your cancer is platinum sensitive
- Your last treatment was chemotherapy that included a platinum drug. Your scans during and after treatment showed that your cancer had either gone away (
complete response) or had shrunk ( partial response)
- You have blood test results that show that you have a normal level of a
markercalled CA-125 (your doctor can tell you this)
- You finished your most recent chemotherapy in the last 8 weeks
- You are willing to provide a sample of cancer tissue that was removed when you had surgery or a previous biopsy
- You have satisfactory blood test results
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You are willing to use reliable contraception during treatment and for 6 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
- Your cancer has spread to your spinal cord or brain (if you have no symptoms and have been stable for the past month you will be able to join)
- You had fluid (ascites) drained from your tummy area during your last 2 chemotherapy cycles or before being put into your group in this trial
- You have had any cancer treatment in the past 2 weeks
- You still have any moderate side effects from previous treatment
- You have had minor surgery in the past 5 days or major surgery in the past 3 weeks
- You have had another drug similar to rucaparib, apart from iniparib
- You have another cancer apart from successfully treated non melanoma skin cancer, breast cancer more than 3 years ago or any other cancer more than 5 years ago and there hasn’t been any sign of it since
- You have a problem with your
digestive systemthat affects how you absorb tablets
- You have taken any medication that strongly affects body proteins called cytochrome P enzymes in the past week
- You have HIV, hepatitis B or hepatitis C
- You have any other condition that could affect you taking part in this trial
- You are pregnant or breastfeeding
This is an international phase 3 trial. The researchers need 540 women to join the trial.
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. There are 2 groups in the trial
- 2 out of every 3 women have rucaparib (you have twice as much chance of being put in this group)
- 1 out of every 3 women has a dummy drug (placebo)
Rucaparib is a tablet. Your doctor will tell you how many you need to take. You take them twice a day with a glass of water. You have an electronic diary to record when you take your tablets and how many.
On certain days, you take your tablets at the hospital and not at home. Your doctor will tell you when these days are.
There are some foods and medicines that you can’t have when taking rucaparib. Your doctor will tell you about this.
You can continue with treatment as long as it is helping you and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire before you start treatment, every month 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.
The trial team will ask for a sample of tissue (biopsy) at the end of your treatment and another if your cancer gets worse. You don’t have to agree to this. You can still take part in the trial.
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
- Urine test
- CT scan
During treatment you see the doctor once a week for the first 2 weeks, at week 4 and week 6 then every 4 weeks. You have a CT scan every 12 weeks.
At the end of treatment you see the doctor for the same tests you had at the start. You see the doctor again a month later and then every 3 months to see how you are.
Rucaparib is a new drug and there may be side effects we don’t know about yet. The most commonly reported side effects include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Diarrhoea or constipation
- Loss of appetite and changes to taste
- A change to the way your liver or kidneys work
- An increase in your cholesterol levels
Your doctor will talk to you about the possible side effects before you agree to take part in the study.
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.
Prof Jonathan Ledermann
Clovis Oncology Inc
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer