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.
A trial looking at carboplatin, gemcitabine, bevacizumab and pegylated liposomal doxorubicin for ovarian cancer (OPSROC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the drugs carboplatin, gemcitabine, bevacizumab and pegylated liposomal doxorubicin to treat ovarian cancer. The trial is for women who have ovarian cancer that has come back more than 6 months after initially responding to
The trial is for women who have
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.
Doctors usually treat ovarian cancer with surgery followed by chemotherapy. One chemotherapy drug they often use is a platinum drug called carboplatin. If your cancer responds to this type of treatment and doesn’t get worse again for more than 6 months, it is described as being platinum sensitive. If your cancer comes back, you may have carboplatin again alongside other anti cancer drugs.
In this trial, the researchers are looking at the drugs bevacizumab, gemcitabine and pegylated liposomal doxorubicin.
Gemcitabine is a chemotherapy drug that doctors can use in combination with carboplatin to treat ovarian cancer.
Pegylated liposomal doxorubicin is a different form of the chemotherapy drug doxorubicin.
The researchers think that the combination of bevacizumab, carboplatin and pegylated liposomal doxorubicin may be better than carboplatin, bevacizumab and gemcitabine. They also think the side effects may be less severe.
We know from research that adding bevacizumab to the chemotherapy drugs carboplatin and gemcitabine then continuing with bevacizumab alone afterwards may prolong the time before ovarian cancer comes back.
In this trial half the women will have carboplatin, bevacizumab and pegylated liposomal doxorubicin. The other half will have carboplatin, bevacizumab and gemcitabine. Everyone will then continue to have bevacizumab alone after their chemotherapy.
The aims of the trial are to find out
- Which combination of drugs delays ovarian cancer coming back the longest
- What the side effects of each combination of drugs are
- How each combination of drugs affects quality of life
Who can enter
You may be able to join this trial if you have one of the following
And all of the following apply
- Your cancer has come back more than 6 months after treatment with
- 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 test results
- You are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you could get pregnant
- You are at least 18 years old
You cannot join this trial if any of these apply. You
- Have a type of ovarian, fallopian tube or primary peritoneal cancer called non epithelial or borderline cancer
- Have cancer that has (or may have) spread to your brain, or is pressing on your spinal cord (spinal cord compression)
- Are having any other anti cancer treatment
- Have had radiotherapy to your tummy (abdomen) or the area between your hips (pelvis)
- Have had an experimental drug as part of a clinical trial in the last month
- Have surgery within 4 weeks of starting bevacizumab in this trial
- Are taking 325mg or more of aspirin a day
- Have had another cancer in the last 5 years apart from some successfully treated
early cancers. You may be able to join if you had a cancer over 5 years ago that was successfully treated
- Have high blood pressure unless it is controlled with medication
- Have certain heart problems or certain problems with your
digestive system(the trial team can advise you about this)
- Have had a significant injury in the past month
- Have had a blood clot or bleeding problem in the last 6 months
- Are taking certain medications that thin your blood (the trial team can advise you about this)
- Have any other medical condition or mental health problem that the trial thinks could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 3 trial. The trial team need 654 women to join. 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. You have one of the following treatment plans
- Carboplatin, bevacizumab and gemcitabine
- Carboplatin ,bevacizumab and pegylated liposomal doxorubicin
You have all 3 drugs as a drip into your vein.
If you have carboplatin, bevacizumab and gemcitabine, you have them every 3 weeks on the same day. Each 3 week period is called a cycle of treatment. You have 6 cycles of carboplatin and gemcitabine. You continue having bevacizumab every 3 weeks after finishing carboplatin and gemcitabine.
If you have carboplatin and pegylated liposomal doxorubicin, you have them every 4 weeks. Each 4 week period is a cycle of treatment. You have 6 cycles of carboplatin and pegylated liposomal doxorubicin. You start having bevacizumab every 2 weeks when you start treatment. After finishing pegylated liposomal doxorubicin and carboplatin you continue to have bevacizumab on its own every 3 weeks.
When you first have bevacizumab it will take 1½ hours. From then on it will take an hour or half an hour each time. Everyone continues having bevacizumab as long as it is helping and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire before you start treatment, every 3 months during treatment, when you finish treatment and 6 months afterwards. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You see the doctor to have some tests before you take part in the trial. These tests include
- A physical examination
- Blood tests
- Urine test
- CT scan or MRI scan
- Heart trace (
- Heart scan (
- Chest X-ray
Depending on which combination of treatment you’re having, you see the doctor every 2 or 3 weeks for a physical examination, blood tests and urine test.
When you are having bevacizumab only, you see the doctor every 3 weeks for a physical examination, blood test and urine test.
During treatment you have a CT scan or MRI scan and a heart scan every 3 months.
You see the doctor a month after finishing treatment for a physical examination and blood tests. You then see the doctor and have a CT scan or MRI scan every 6 months for 5 years from the start of your treatment.
The most common side effects of bevacizumab are
- High blood pressure
- Slow wound healing
- Numbness, tingling or pain in your hands or feet
- A drop in blood cells causing an increased risk of infection, bruising or bleeding
- Feeling or being sick
- Tiredness (fatigue)
The most common side effects of carboplatin are
- Feeling or being sick
- Loss of hearing
- A drop in blood cells causing an increased risk of infection, bruising or bleeding problems, tiredness and breathlessness
The most common side effects of gemcitabine are
- A drop in blood cells
- Breathing problems
- Flu like symptoms such as fever and chills
- Swelling due to a build up of fluid
The most common side effects of pegylated liposomal doxorubicin are
- A drop in blood cells
- Loss of appetite
- Constipation or diarrhoea
- Feeling or being sick
- Skin rash and nail changes
- Numbness, tingling or pain in your hands and feet
The trial team will talk to you about all the possible side effects before you agree to take part in the trial.
We have more information on
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.
Dr Ros Glasspool
AGO Study Group
Cancer Research UK
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUKE/13/027.