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.

Cancer type:

Ovarian cancer




Phase 3

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 platinum chemotherapy drugs Open a glossary item. This trial is supported by Cancer Research UK.

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.

More about this trial

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.

Bevacizumab (also called Avastin) is a type of biological therapy called a monoclonal antibody. It seeks out cancer cells by looking for particular proteins.

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. Pegylation Open a glossary item is a way of treating drugs to change the way they behave in your body. This may help doxorubicin stay in your bloodstream longer so that more of it reaches the cancer cells.

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 platinum chemotherapy Open a glossary item
  • 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 Open a glossary item. 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 Open a glossary item (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

Trial design

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

11765 Trial Diagram

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.

Hospital visits

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 (ECG Open a glossary item)
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • 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.

Side effects

The most common side effects of bevacizumab are

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

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

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 Ros Glasspool

Supported by

AGO Study Group
Cancer Research UK
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer

Other information

This is Cancer Research UK trial number CRUKE/13/027.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11765

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:

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