A trial of farletuzumab with chemotherapy for ovarian cancer that has come back

Who can enter

You may be able to enter this trial if you

• Have ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer that has come back more than 6 months but less than 2 years after having treatment with carboplatin and a taxane drug
• Have cancer that can be seen and measured on a scan and your doctors think more treatment with carboplatin and a taxane drug would be right for you
• Are well enough to take part and are able to look after yourself, even if you may not be well enough to do everything you normally do (Karnofsky performance status of 70 or more)
• Have satisfactory blood test results
• Are willing to use a reliable form of contraception during the trial and for 2 months afterwards if there is any chance you could become pregnant
• Are at least 18 years old

You cannot enter this trial if you

• Have a type of cancer called mucinous ovarian cancer
• Have cancer that has spread to your brain or spinal cord (central nervous system)
• Have cancer that did not respond to platinum chemotherapy, or your cancer has come back less than 6 months (or more than 2 years) after that treatment
• Have had another treatment since your cancer has come back
• Have had an experimental drug as part of another clinical trial in the last 4 weeks
• Have already had farletuzumab
• Have had an allergic reaction to another monoclonal antibody
• Cannot have a taxane drug for some reason
• Have had another type of cancer in the last 5 years
• Are taking other drugs that affect your immune system or steroids unless you are taking a low dose
• Have had a heart attack in the last 6 months, have heart pain (angina) that is not well controlled with medication, or have other heart problems that are a cause for concern
• Have another serious medical condition including serious infections
• Are pregnant or breastfeeding

Trial design

This international phase 3 trial will recruit about 1,100 women. 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. And neither of you will know which group you are in either. This is called a double blind trial.

Everybody taking part will have carboplatin and a taxane drug such as paclitaxel. You have both drugs through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment.

As well as having chemotherapy,

• People in group 1 have a low dose of farletuzumab though a drip into a vein once a week
• People in group 2 have a slightly higher dose of farletuzumab once a week
• People in group 3 have a dummy drug (placebo) once a week

You have about 6 cycles of this treatment. This is called the treatment period. Then you stop having chemotherapy. But as long as it is not causing bad side effects, you can carry on having farletuzumab (or placebo) once a week for as long as it helps you. This is called the maintenance period.

Some people may also carry on having chemotherapy for more than 6 cycles if the trial doctor thinks it is the best treatment for them.

The trial team may ask you to give some extra blood samples during the trial. This is so they can learn more about what happen to the drug in the body (pharmacokinetics) and how it interacts with the chemotherapy drugs.

Hospital visits

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

• Physical examination and review of your medical history
• Blood and urine tests
• Heart trace (ECG)
• CT scan or MRI scan

During both the treatment period and the maintenance period, you go to hospital or to see your doctor once a week for tests and examinations.

You have a CT or MRI scan every 6 weeks during the treatment period and every 9 weeks during the maintenance period.

After you finish treatment, you go back and see the trial team about a week later and have more blood tests as well as an ECG. You see them again 4 weeks and 8 weeks later. You have blood tests at each of these visits.

After that, a member of the trial team will contact you by phone to see how you are once a month for the next 9 months, then once every 2 months until the end of the trial. They may ask you to have more CT scans or they will look at results of scans you are already having as part of your normal care.

Side effects

As farletuzumab is an experimental drug, there may be some side effects we don’t know about yet. Possible side effects that doctors know about so far include allergic and infusion reactions (fever, chills, rash, itching and flushing).

There is more about the possible side effects of carboplatin and paclitaxel on CancerHelp UK.

The study team will explain all of the possible risks to you before you enter the study.