A trial looking at chemotherapy with or without bevacizumab for advanced ovarian cancer (ICON8B)

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 3

This trial is looking at chemotherapy with or without bevacizumab for advanced ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma. 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. This trial is supported by Cancer Research UK.

More about this trial

Doctors usually treat advanced ovarian cancer with surgery and chemotherapy. The most common chemotherapy drugs doctors give are carboplatin and paclitaxel. They can also use a biological therapy drug called bevacizumab.

You usually have chemotherapy once every 3 weeks. Each 3 week period is a cycle of treatment. You usually have 6 cycles all together. This is known as the standard treatment. Open a glossary item

Some women taking part have surgery first, followed by 6 cycles of chemotherapy. And some women have 3 cycles of chemotherapy first, then they have surgery followed by 3 more cycles of chemotherapy.

The aims of the trial are to see:

if weekly chemotherapy with bevacizumab is better than 3 weekly chemotherapy with bevacizumab for women with advanced ovarian cancer
which treatment causes more or fewer side effects
which treatment offers better quality of life
whether it is safe to use bevacizumab for women who are having surgery and chemotherapy

Who can enter

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

have been diagnosed with ovarian cancer, fallopian tube cancer or primary peritoneal cancer
have cancer that is stage 3 or 4
are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
have satisfactory blood test results
are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you could become pregnant
are female and at least 18 years old

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

have cancer that has spread to your brain or spinal cord (central nervous system)
have ovarian cancer that is not epithelial, certain rare types of peritoneal cancer (the trial doctor can advise you about this) or a borderline tumour
have already had chemotherapy, biological therapy or hormone therapy for ovarian cancer
have had any other cancer in the last 5 years apart from DCIS, carcinoma in situ of the cervix or non melanoma skin cancer that have been successfully treated, or cancer of the womb lining that was stage 1A and low grade
have ever had radiotherapy to your tummy (abdomen) or the area between your hip bones (pelvis)
are going to have chemotherapy directly into your abdomen (intraperitoneal chemotherapy)
are having any other experimental drug
are due to have surgery within 4 weeks of starting bevacizumab in this trial
have damage to your nerves (peripheral neuropathy)
have protein in your urine (proteinuria)
have had a mini stroke (TIA), stroke or have had bleeding in your brain in the last 6 months
have high blood pressure not controlled by medication
have had a heart attack or angina not controlled by medication in the last 6 months
have heart failure or problems with the rhythm of your heart that is not well controlled
have any medical condition that causes abnormal bleeding or blood clotting
have chronic inflammatory bowel disease, a stomach ulcer or a hole (perforation) in the lining of your stomach or bowel
have widespread cancer in your lower bowel and rectum or your bowel is blocked (obstructed)
have an abdominal (tummy) fistula which is causing problems
have a broken bone or a wound that isn’t healing
have unexplained bloating in your abdomen
are taking 325mg or more of aspirin a day
need to have a lot of dental work during the time you would be on treatment
are known to be sensitive to carboplatin, paclitaxel, bevacizumab or their ingredients
have any other medical condition that the trial doctors think could affect your taking part
are pregnant or breastfeeding

Trial design

This is a phase 3 trial. It will recruit about 660 women. 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:

women in group 1 have carboplatin and paclitaxel and bevacizumab once every 3 weeks, treatment lasts a total of 15 months
women in group 2 have carboplatin once every 3 weeks and a lower dose of paclitaxel once a week, treatment lasts a total of 5 months (Please note: The trial team are no longer putting people into this group.)
women in group 3 have carboplatin and bevacizumab once every 3 weeks and a lower dose of paclitaxel once a week, treatment lasts a total of 15 months

ICON8B trial diagram

You have carboplatin, paclitaxel and bevacizumab through a drip into a vein.

Women in groups 1 and 3 then go on to have bevacizumab once every 3 weeks over 39 weeks (13 cycles of treatment).

You may have surgery followed by 6 cycles of chemotherapy. Or you may have 3 cycles of chemotherapy followed by surgery, then 3 more cycles of chemotherapy. But everybody will have chemotherapy for a total of 18 weeks.

If you have surgery during treatment
Women in group 3 will not have any chemotherapy in the third week of the third treatment cycle (the one before surgery). This gives a bit longer to recover before surgery which is a couple of weeks later.

Women in groups 1 or 3 will not have bevacizumab as part of their third treatment cycle. This is because bevacizumab can cause problems with bleeding and healing. You will not have bevacizumab within 4 weeks before or after your surgery.

Everybody will be asked to fill out a questionnaire:

before starting treatment
before each cycle of treatment starting with your second cycle
at follow up appointments after you finish treatment for up to 5 years.

You will also fill in a questionnaire if:

you are having surgery during treatment you fill it out before your surgery
your cancer comes back

The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.

The trial team will ask to take extra blood samples and to take a sample of tissue when you have (or had) surgery. They will look for substances called biomarkers Open a glossary item in these samples. By looking at these they hope to be able to work out who would benefit most from having weekly chemotherapy.

They also want to look for biomarkers that show that a cancer is starting to grow again before it shows on scans. And they want to look at how genes affect ovarian cancer and how people respond to treatment.

You don’t have to give these extra samples for research if you don’t want to. You can still take part in the trial.

Hospital visits

You will see the trial doctors and have some tests before you start treatment. The tests include:

physical examination
chest X-ray
blood tests
heart trace (ECG (electrocardiogram, heart monitor))
CT scan or MRI scan

Women in group 1 go to hospital once every 3 weeks to have their chemotherapy treatment.

After the chemotherapy has finished women in the groups having bevacizumab go to hospital once every 3 weeks for treatment.

You have blood tests before every treatment and you see the doctors regularly.

If you are due to have surgery during your treatment you will have a scan before surgery and 4 weeks after surgery. Everybody will have a scan after 6 cycles of treatment and then 16 months after you joined the trial.

After you finish your treatment you see the doctors:

every 6 weeks for up to 16 months after you joined the trial
then every 3 months until you have been in the trial for 2 years
and every 6 months for 6 years after that

Side effects

The possible side effects of carboplatin and paclitaxel include:

feeling or being sick
tiredness (fatigue)
a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
hair loss
aches and pains
pins and needles or tingling in your hands and feet (peripheral neuropathy)
ringing in the ears
mood swings

Some women can have allergic reactions to paclitaxel. To reduce the risk of this you will have steroids and anti-allergy medication before each chemotherapy treatment.

The most common side effects of bevacizumab include: