A trial looking at abiraterone for women with ovarian, primary peritoneal or fallopian tube cancer (CORAL)

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 looking at a drug called abiraterone for ovarian cancer. This trial is supported by Cancer Research UK.

The trial is recruiting women with ovarian, primary peritoneal or fallopian tube cancer whose cancer has come back within a year of their last treatment. 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

Doctors usually treat ovarian cancer with surgery and chemotherapy. But sometimes the cancer comes back after treatment. Researchers are looking for new treatments that might help women in that situation. In this trial they are looking at a drug called abiraterone.

Abiraterone is a type of hormone therapy. It blocks the body making androgens and oestrogens. These hormones can stimulate the cancer to grow. Doctors already use it to treat men with prostate cancer and it is now part of their standard treatment. It has also been looked at in trials for women with breast cancer.

The aims of this trial are to

  • Find out if abiraterone helps women with ovarian, primary peritoneal or fallopian tube cancer that has come back within a year of their last treatment
  • Learn more about the side effects
  • Find substances in the blood (biomarkers) Open a glossary item that may help to predict who will benefit from having abiraterone

Who can enter

You may be able to join this trial if all of the following apply.

  • You have epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer that has come back within a year of your last treatment
  • You have been through the menopause Open a glossary item
  • You haven’t had hormone therapy in the past
  • You have had at least one treatment with platinum chemotherapy Open a glossary item
  • The trial team can test a sample of tissue (biopsy Open a glossary item) that was removed when you had your ovarian cancer surgery or you are willing to have a sample of tissue taken
  • You are well enough to take part
  • You have satisfactory blood test results
  • You are at least 18 years old

You cannot join this trial if any of these apply.

  • Your cancer has spread to your brain or spinal cord
  • You have certain types of epithelial ovarian cancer called mucinous, clear cell, mixed mesodermal (MMMT) or non epithelial ovarian cancer (your doctor can tell you more about this)
  • You have had radiotherapy or chemotherapy in the last 3 weeks unless the radiotherapy was to help control your cancer symptoms
  • You haven’t recovered from the side effects of other treatment, unless they are mild
  • You have high levels of a hormone called aldosterone in your blood
  • Your pituitary gland Open a glossary item cannot make enough hormones
  • You have a blockage in your bowel (bowel obstruction)
  • You have had major surgery in the last 4 weeks
  • You are taking a drug called warfarin to thin your blood, unless you are taking it for a blood clot in your leg (deep vein thrombosis) or a blood clot in your lung (pulmonary embolism), in which case the doctors in the trial can give you a different drug to take
  • You are known to have hepatitis B or hepatitis C
  • You have an autoimmune disease Open a glossary item and you may need to take steroids (the trial doctor can advise you about this)
  • You have serious heart condition
  • You have high blood pressure that can’t be controlled with medication
  • You have any other cancer that needs treatment
  • You can’t have a steroid drug called  prednisolone for any reason
  • You are taking part in, or plan to take part in, another trial
  • You have any other medical condition that the trial team think could affect you taking part

Trial design

This is a phase 2 trial. The researchers need 50 women to join. Everybody taking part will have abiraterone.

You have abiraterone as tablets. You take 4 abiraterone tablets once a day. You also have a steroid drug called prednisolone that you take once a day to help reduce some of the possible side effects.

As long as you don’t have bad side effects, you can carry on taking abiraterone for as long as your doctor thinks it is helping to stop the growth of your cancer.

If you agree to take part in this trial, the researchers will ask you to give extra blood samples to study your genes Open a glossary item. They want to learn more about how genes affect the way people respond to abiraterone. The samples will be stored safely and used only for research purposes.

They may also ask your permission to take extra tissue samples (biopsies Open a glossary item) from your tumour. This is so they can learn more about how the drugs affect ovarian cancer cells. If you agree to this, your doctor will explain more about how they will take the biopsies. If you do not wish to give your permission for the biopsies, you can still take part in the trial.

Hospital visits

You will see the doctor and have some tests before you can take part in the trial. The tests include

  • A physical examination
  • Heart trace (ECG Open a glossary item)
  • CT scan or MRI scan of your chest, abdomen and pelvis

You then have a further appointment with the doctor for some final tests before you start treatment.

Every month, you will see the trial doctor for a check up and some blood tests. Every 3 months, you have a CT or MRI scan to see how well the treatment is working.

If the treatment stops working, you see the trial doctor 4 weeks later for a check up and blood tests. After that, the trial team will continue to see how you are at your routine hospital visits.

Side effects

The most common side effects of abiraterone are

  • Tiredness (fatigue)
  • High blood pressure
  • A low level of potassium Open a glossary item in your blood
  • Urine infection
  • Fluid retention

We have more information about the side effects of abiraterone and prednisolone.

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 Susana Banerjee

Supported by

Cancer Research UK
Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
Janssen-Cilag

Other information

This is a Cancer Research UK trial number CRUKE/12/052.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 10565

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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