A trial of cediranib for women with ovarian cancer at risk of having a bowel obstruction (CEBOC)

Cancer type:

Ovarian cancer
Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is for women with ovarian cancer that has come back or continued to grow after platinum chemotherapy. Platinum chemotherapy includes the drugs cisplatin and carboplatin.

It is for women who have:

  • epithelial ovarian cancer
  • fallopian tube cancer
  • primary peritoneal cancer

Doctors treat these cancers 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

Chemotherapy with a platinum drug Open a glossary item is a possible treatment for ovarian cancer.

After some time, ovarian cancer might start to grow again and spread to other parts of the body. One of the most common places where ovarian cancer spreads to is the tummy (abdomen). This can cause a serious complication called bowel obstruction.  

You usually have more chemotherapy if you have ovarian cancer that has spread to the tummy and you are at risk of bowel obstruction. Paclitaxel (Taxol) is a possible chemotherapy treatment.

In this trial, doctors are looking at a drug called cediranib. Cediranib is a targeted drug called a cancer growth blocker. Doctors think it can block substances (growth factors) that trigger the cancer cells to divide and grow.

The main aim of this trial is to find out whether cediranib and paclitaxel help women with ovarian cancer who are at risk of bowel obstruction.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this trial if all of the following apply:

  • you have ovarian cancer that has spread to your tummy (abdomen) and doctors think that you are at risk of bowel obstruction
  • you have at least 1 area of cancer that can be seen and measured on a scan
  • doctors think that the chemotherapy drug paclitaxel is a suitable treatment for you
  • you have satisfactory blood tests results
  • your heart is working well
  • your thyroid Open a glossary item is working well
  • you can swallow and absorb tablets
  • you are well enough to be up and about for at least half of the day (performance status 0 to 2)
  • you are at least 16 years old
  • you are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility that you could become pregnant

Who can’t take part

Cancer related
You cannot join this trial if any of these apply:

  • your cancer has spread to your brain or the spinal cord, unless you have had treatment for it and it has been stable for the past 28 days
  • you are going to have treatment with bevacizumab (Avastin)
  • you have had surgery or a tumour embolisation Open a glossary item in the last month
  • you have had chemotherapy or radiotherapy in the last 3 weeks, unless it was radiotherapy to help with symptoms (palliative radiotherapy)
  • you are having any other anti cancer treatment
  • you have moderate or severe side effects from previous anti cancer treatment, apart from hair loss and problems with your nerves
  • you have, or your doctors think you may have, acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS)
  • you have had another cancer in the past 5 years apart from carcinoma in situ Open a glossary item of the cervix or basal or squamous cell skin cancer that have been successfully treated

Medical conditions
You cannot join this trial if any of these apply. You:

  • have had a major surgery in the last 2 weeks and you still have side effects from it
  • have heart problems including high blood pressure that isn’t controlled with medication, an irregular heartbeat (arrhythmia), angina that isn’t controlled, or you have had a heart attack in the last 6 months
  • have fits (seizures) that aren’t controlled
  • have taken drugs that affect enzymes called CYP3A in the last 2 to 5 weeks (your doctor can tell you more about this)
  • have had a blood clot in an artery or a stroke Open a glossary item in the last 6 months
  • have had a hole in your stomach or bowel (gastrointestinal perforation)
  • have high levels of protein in the urine
  • have had a bone marrow transplant from a donor (allogeneic bone marrow transplant)
  • have HIV
  • have hepatitis B or hepatitis C
  • have an infection that isn’t controlled
  • have any other medical condition that doctors think could affect you taking part

Other
You cannot join this trial if any of these apply:

  • you are sensitive to olaparib, cediranib, paclitaxel or anything they contain
  • you are pregnant or breastfeeding

Trial design

This is a phase 2 trial. Researchers hope that around 30 women from the UK will take part.

The treatment you have depends on your bowel symptoms.

CEBOC trial diagram

For severe bowel symptoms
You join this group if you have severe bowel symptoms which include:

  • tummy (abdomen) pain
  • swelling that is getting worse
  • changes in your bowel habit
  • other signs seen by doctors on a CT scan

Please note that you can’t join this trial if you already have bowel obstruction. Symptoms of bowel obstruction include feeling sick and severe constipation.

For severe bowel symptoms, you have paclitaxel as a drip into a vein (intravenously). You have it every week, for about 4 months (18 weeks).

During this time, you see the trial doctor regularly and have CT scans. Doctors want to find out whether the treatment is helping you. You then:    

  • continue to have paclitaxel if the cancer stays the same or gets worse
  • join the moderate bowel symptoms group if your cancer gets better

For moderate bowel symptoms
You join this group if you:

  • feel a little sick
  • have some changes in your bowel habit
  • have some swelling and pain in the tummy (abdomen)

 You start paclitaxel and cediranib together.

Cediranib is a tablet that you take every day, at home. Paclitaxel comes as a drip that you have into your bloodstream.

You can have paclitaxel for up to 18 weeks. And you can take cediranib for as long as the cancer stays the same and the side effects aren’t too bad.

You stop paclitaxel and cediranib if your cancer gets worse. And you might be able to start taking cediranib and olaparib every day.

You have cediranib and olaparib for as long as cancer stays the same. This can be for up to 6 months.

After 6 months, or if your cancer gets worse before that, you stop cediranib and olaparib. Your doctor can tell you about other treatments you may have.

Blood tests
You have extra blood tests as part of this trial. Doctors want to look for a change (mutation) in the BRCA gene Open a glossary item which increases the risk of having certain cancers such as ovarian cancer.

You have the extra blood tests before the start of olaparib.

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

  • physical examination
  • heart trace (ECG Open a glossary item)
  • blood tests
  • urine test
  • CT scan

During treatment, you see the trial team every 3 weeks. You have blood tests, heart trace and a physical examination each time you see them.

You have a CT scan every 9 weeks while you are having treatment. This continues for as long as your cancer stays the same and the side effects aren’t too bad.

When you finish treatment, you see the trial team after a month. You then continue to see your doctor as part of your normal follow up.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about the possible side effects before you start the trial.

The most common side effects of paclitaxel are:

The most common side effects of cediranib are:

  • diarrhoea
  • feeling or being sick
  • muscle pain
  • tiredness (fatigue) during and after treatment
  • heart, thyroid and kidney problems
  • an increased risk of bleeding
  • a sore mouth and a hoarse voice

The most common side effects of olaparib are:

  • a drop in the number of blood cells increasing your risk of infection, tiredness and breathlessness
  • diarrhoea
  • tiredness (fatigue) during and after treatment and dizziness
  • feeling or being sick and indigestion
  • loss of appetite and taste changes
  • headaches
  • kidney problems

We have more information about the possible side effects of paclitaxel and olaparib.

Location

Manchester

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

Professor Gordon Jayson

Supported by

AstraZeneca
Centre for Trials Research (Cardiff University)
University of Manchester

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15322

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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