A trial looking at low dose cyclophosphamide and nintedanib for ovarian cancer (METRO-BIBF)

Cancer type:

Ovarian cancer

Status:

Results

Phase:

Phase 2

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 targeted drug Open a glossary item called a cancer growth blocker Open a glossary item. 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 (placebo Open a glossary item).

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 Open a glossary item

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.

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:

  • 59 had low dose cyclophosphamide and nintedanib
  • 58 had low dose cyclophosphamide and a dummy drug 

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: 

  • 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. 

Side effects
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)
  • diarrhoea 

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. 

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 (peer reviewed Open a glossary item) 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.

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Marcia Hall

Supported by

Boehringer Ingelheim
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUKE/11/024.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8284

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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