
"I am glad that taking part in a trial might help others on their own cancer journey.”
This trial looked at adding nintedanib to cyclophosphamide for ovarian cancer that had come back.
It was open to women who had:
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.
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 called a
. It stops signals that cancer cells use to divide and grow.
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:
The team found that adding nintedanib to cyclophosphamide didn't work. It didn't improve treatment for ovarian cancer that had come back.
Trial design
This was a phase 2 trial. There were 2 treatment groups. 117 people took part. They were put into a treatment group at random:
Results
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.
It was:
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:
Other findings included:
Quality of life
The team looked at how treatment affected quality of life. They didn’t find a difference between the 2 treatment groups.
Side effects
The team looked at the number of people in each group who had bad to severe side effects. They found it was:
The most common side effects were:
People who had nintedanib also had bad to severe:
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:
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.
Conclusion
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 () and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Marcia Hall
Boehringer Ingelheim
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.
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”