A trial looking at cabazitaxel for cancer of the penis that has come back after treatment (JAVA-P)

Cancer type:

Penile cancer
Secondary cancers

Status:

Results

Phase:

Phase 2

This trial looked at a chemotherapy drug called cabazitaxel to improve treatment for cancer of the penis. Cancer of the penis is also called penile cancer. 

It was for men whose cancer had grown into surrounding tissue or had spread elsewhere in the body. This is locally advanced or advanced cancer. 

This trial was open for people to join between 2014 and 2017, and the team published the results in 2019. 

More about this trial

You might have chemotherapy for advanced cancer of the penis. But sometimes it can start to grow again. So doctors are looking for ways to improve treatment.

In this trial, researchers looked at a chemotherapy drug called cabazitaxel (Jevtana). 

The main aims of the study were to find out:

  • if cabazitaxel works for cancer of the penis that has come back 
  • more about the side effects
  • more about quality of life 
     

Summary of results

The trial team found that cabazitaxel did not work for cancer of the penis that had come back. But the side effects weren’t too bad.

About this trial
This was a phase 2 trial

The researchers planned for 17 men to take part. They looked at the results after 9 men had joined. Of those:

  • 7 had cancer that had spread elsewhere in the body
  • 2 had cancer that had grown into surrounding tissues

Everyone had cabazitaxel. They had up to 6 cycles of treatment Open a glossary item. They had scans Open a glossary item after the 2nd and 4th cycle of treatment to see if the cancer got smaller. The plan was to recruit more people if the cancer had shrunk in anyone. 

Results
The team checked the scans to see whose cancer had gone away completely or a little bit.

This had not happened in anyone so no more people joined the trial and it closed. 

Quality of life
The team looked at how treatment affected quality of life Open a glossary item. Only 3 people completed the quality of life questionnaires at various time points. They reported that treatment did not change their quality of life.

Side effects
Most people had side effects that were mild. 

3 people had more severe side effects. These included:

  • a drop in the number of red blood cells (anaemia Open a glossary item)
  • a drop in the number of neutrophils Open a glossary item which led to a serious infection (neutropenic sepsis)
  • being sick 

There were no treatment delays or dose reductions due to side effects. 

Conclusion
The trial team concluded that cabazitaxel didn’t work for penile cancer that had come back. So the team closed the trial earlier than planned. They think it might be worth looking at cabazitaxel in combination with other drugs for cancer of the penis rather than having it as a treatment on its own. 

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 Amit Bahl

Supported by

NIHR Clinical Research Network: Cancer
Sanofi Aventis
University Hospitals Bristol NHS Foundation Trust

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12584

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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