A trial looking at chemotherapy with or without bevacizumab for mucinous ovarian cancer (mEOC)

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 comparing 2 different chemotherapy combinations with or without bevacizumab (Avastin) for a rare type of ovarian cancer called mucinous epithelial ovarian cancer. This trial is supported by Cancer Research UK.

Doctors usually treat ovarian cancer with surgery and chemotherapy. But doctors think that standard chemotherapy drugs used for ovarian cancer are not necessarily the best for this particular type. Mucinous ovarian cancer has a number of similarities with mucinous cancer found in the digestive system Open a glossary item . So doctors think that chemotherapy used for this type of cancer might be useful for treating mucinous ovarian cancer. But they are not sure yet.

This trial will compare standard chemotherapy with a new combination of chemotherapy already used to treat mucinous cancers of the digestive system. Doctors also want to try a newer drug called bevacizumab that doctors use to treat other types of cancer. Bevacizumab is a type of biological therapy called a monoclonal antibody.

The aim of the trial is to find out

Which treatment works better to control cancer growth
More about the side effects

Who can enter

You can enter this trial if you

Have newly diagnosed stage 2, 3 or 4 mucinous cancer of the ovary or fallopian tube or you have stage 1 cancer that has come back and you have not had chemotherapy
Are well enough to take part (performance status 0, 1 or 2)
Are willing to use reliable contraception if there is any chance that you could become pregnant
Have satisfactory blood and urine test results
Are at least 18 years old

You cannot enter this trial if

You have non mucinous epithelial ovarian cancer
You have primary peritoneal cancer
You have had chemotherapy, radiotherapy or any experimental treatment for ovarian or rectal cancer in the past
Your cancer has spread to your brain
You have significant heart problems
You have had a mini stroke (TIA), a stroke or bleed into the brain in the last 6 months
You have ever had numbness or tingling in fingers or toes (peripheral neuropathy )
You have a wound, ulcer or bone fracture that has not healed properly
You have significant bleeding problems or take a drug to thin the blood called warfarin
You take aspirin and cannot stop taking it (you should not stop taking medication without talking to your doctor)
You take drugs called bisphosphonates
You have any surgery planned while you are having treatment on this trial
You have high blood pressure that is not controlled with medication
You had a severe injury a month before starting bevacizumab treatment
You have had any other type of cancer in the last 5 years apart from cervical carcinoma insitu or basal cell skin cancer that has been successfully treated, or womb (endometrial) cancer if it was grade 1 or 2 and stage 1A
You are pregnant or breastfeeding
You have any other medical condition that the trial doctors think could prevent you from taking part

Trial design

332 patients will take part in this trial. It is a randomised trial. The people taking part will be put into 4 different groups by a computer. Neither you nor your doctor can decide which group you are in.

If you are in group 1 or 2 you will have carboplatin and paclitaxel. If you are in group 3 or 4 you will have oxaliplatin and capecitabine. The people in group 2 and 4 will also have bevacizumab.

You have the drugs in this trial in 3 week cycles of treatment. Everyone taking part in the trial will have up to 6 cycles of treatment.

Groups 1 and 2 will have carboplatin, and paclitaxel as a drip into a vein once every 3 weeks. Groups 3 and 4 will have oxaliplatin as a drip into a vein once every 3 weeks. They will also take capecitabine as a tablet everyday for the first 2 weeks of each treatment cycle and then one week with no treatment.

If you are in groups 2 or 4, you will have bevacizumab as a drip into a vein on the same day as your other IV chemotherapy drugs. When your chemotherapy treatment finishes you will continue to have bevacizumab once every 3 weeks. You will have up to 12 cycles of treatment.

The researchers may ask your permission get a sample of the cancer tissue that was taken when you had surgery. They will study these samples to learn more about this type of cancer and how the treatment works. If you don’t want to give these samples, you don’t have to. You can still take part in the trial.

You will fill out a questionnaire when you join the trial, during treatment and at some of your follow up appointments. The questionnaires will ask about any side effects you have had and how you have been feeling. This is called a quality of life study.

Hospital visits

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

Physical examination
ECG
CT scan of your chest, stomach and lower abdomen (pelvic area)
Blood tests
Urine tests

You have your chemotherapy in the outpatient department. You have blood and urine tests before each treatment cycle begins.

You will have a CT scan or MRI scan after your third cycle of treatment and a month after your 6th cycle. After that, you have a scan at week 30, week 42, at the end of the first year, and then every 6 months in the next year and once a year for the following 3 years.

After you finish treatment, you go to the hospital to see the trial team every 6 weeks in the first year, every 3 months in the 2nd year and every 6 months for the next 3 years.

Side effects

All treatments have side effects. The most common side effects of the chemotherapy drugs used in this trial are

Feeling or being sick
Sore mouth
Loss of appetite
Tiredness (fatigue)
A drop in blood cells causing an increase risk of infection, bleeding problems, tiredness and breathlessness

The most common side effects of bevacizumab include