"I am glad that taking part in a trial might help others on their own cancer journey.”
A trial looking at low dose cyclophosphamide and nintedanib for ovarian cancer (METRO-BIBF)
This trial looked at adding nintedanib to cyclophosphamide for ovarian cancer that had come back.
It was open to women who had:
- ovarian cancer
- fallopian tube cancer
- primary peritoneal cancer
Doctors treat these cancers in the same way. When we use the term ovarian cancer in this summary, we are referring to all 3.
This trial was open for women to join between 2014 and 2016. The team published the results in 2020.
Cancer Research UK supported this trial.
More about this trial
The usual treatment for ovarian cancer is surgery, followed by chemotherapy. But ovarian cancer may come back after chemotherapy. Researchers are looking for treatments to help people in that situation. In this trial they looked at 2 drugs called cyclophosphamide and nintedanib.
Cyclophosphamide is a chemotherapy drug used to treat ovarian cancer. When the team did this trial was there some research that had looked at cyclophosphamide. It found that a low dose of the drug as a tablet could help to control ovarian cancer.
Nintedanib is a type of
In this trial some people had low dose cyclophosphamide and nintedanib. And some people had low dose cyclophosphamide and a dummy drug (
The main aims of the trial were to:
- see if adding nintedanib to low dose cyclophosphamide
- improves treatment learn more about the side effects
- see how treatment affects
quality of life
Summary of results
The team found that adding nintedanib to cyclophosphamide didn't work. It didn't improve treatment for ovarian cancer that had come back.
This was a phase 2 trial. There were 2 treatment groups. 117 people took part. They were put into a treatment group at random:
- 59 had low dose cyclophosphamide and nintedanib
- 58 had low dose cyclophosphamide and a dummy drug
The team looked at the median overall survival. This is the time from treatment to the point at which half of the patients are living.
- 6.8 months in people who had cyclophosphamide and nintedanib
- 6.4 months in people who had cyclophosphamide and a dummy drug
The team also looked at how long people lived before their cancer started to grow again. At 6 months the team found little difference between the 2 different groups. It was:
- 2.9 months in people who had cyclophosphamide and nintedanib
- 2.6 months in people who had cyclophosphamide and a dummy drug
Other findings included:
- people who had a drug called bevacizumab in the past stopped treatment earlier. They had about 52 days less time on treatment.
- more people than expected had treatment for at least 6 months
Quality of life
The team looked at how treatment affected quality of life. They didn’t find a difference between the 2 treatment groups.
The team looked at the number of people in each group who had bad to severe side effects. They found it was:
- just over 6 out of 10 (64%) people who had cyclophosphamide and nintedanib
- just over 5 out of 10 (54%) people who had cyclophosphamide and a dummy drug
The most common side effects were:
- a drop in the number of white blood cells called lymphocytes
- tiredness (fatigue)
- being sick
People who had nintedanib also had bad to severe:
- risk of infection (neutropenia)
People who had low dose cyclophosphamide and the dummy drug had more problems with tummy pain.
There were a lot of side effects in the first 6 weeks of treatment. It was difficult to work out if:
- nintedanib was causing them
- they were symptoms that cancer can cause
The data monitoring committee looked at the side effects. This committee monitors the safety and design of trials. They looked at the number of side effects and how bad they were. They did this after 61 people had joined the trial.
The committee recommended the team reduce the dose of nintedanib. People who joined the trial after this point had the lower dose.
The research team concluded that adding nintedanib to cyclophosphamide didn’t work. It didn't increase the length of time people lived.
There was some evidence that low dose cyclophosphamide helped a few people. The trial team suggest it might be a suitable treatment option for some people.
Even so, all trial results help doctors and researchers understand more about different cancers. And the best way to treat them.
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (
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.
Dr Marcia Hall
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUKE/11/024.