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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Penile cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at a chemotherapy drug called cabazitaxel for cancer of the penis. It is for men whose cancer has spread into surrounding tissue (is locally advanced), or to another part of the body and has come back after treatment.

More about this trial

If cancer of the penis is locally advanced or has spread to another part of the body, doctors can use chemotherapy to treat it. But sometimes the cancer can start to grow again. So doctors are trying to improve treatment for men in this situation.

In this trial, researchers are looking at a chemotherapy drug called cabazitaxel (also known as Jevtana). The aims of the study are find out

  • If cabazitaxel helps men with cancer of the penis
  • More about the side effects and how it affects quality of life

Who can enter

You may be able to join this trial if all of the following apply.

  • You have squamous cell cancer of the penis that has grown into surrounding tissues or lymph nodes Open a glossary item, or has spread to another part of the body and has come back after treatment
  • You have had chemotherapy  that included either cisplatin and fluorouracil (also called 5FU) or a drug combination called TPF (this includes the drugs docetaxel, cisplation and fluorouracil)
  • Your cancer can be seen on a scan
  • You are well enough to be up and about for at least half the day (performance status of 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 1 year afterwards if you are sexually active and there is any chance your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have a rare type of penile cancer called veruccous cancer of the penis
  • Have cancer that started in the tube that carries urine through the penis (your urethra Open a glossary item)
  • Have nerve damage affecting your hands or feet (peripheral neuropathy) unless it is only mild
  • Can’t have chemotherapy (your doctor can explain this)
  • Have an infection and you are having antibiotic or antifungal treatment
  • Have a medical condition such as diabetes that is not controlled with medication
  • Have had high blood pressure that isn’t well controlled with medication
  • Are having treatment with drugs such as ketoconazole, itraconazole or clarithromycin (you may be able to take part in the trial if you stop taking this, but it is important that you don’t stop any other treatment before discussing it with your doctor)
  • Have had a stroke, heart attack or unstable heart pain (angina) in the last 6 months
  • Have any other serious heart problem
  • Have any other cancer
  • Have taken part in another clinical trial in the last month
  • Have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
  • Are known to be very sensitive to docetaxel
  • Are planning on having the yellow fever vaccine

Trial design

This is a phase 2 trial. The researchers need 17 men to take part.

Everyone taking part will have cabazitaxel. You have 3 week cycles of treatment. You have cabazitaxel as a drip into a vein once every 3 weeks. It takes about an hour each time. As long as you don’t have bad side effects and your cancer doesn’t get worse, you have up to 6 cycles of treatment in total. This will take about 18 weeks.

The trial team will ask everyone taking part to complete some questionnaires before treatment starts and then regularly throughout treatment. These are called quality of life questionnaires. They look at how the treatment affects you physically and emotionally.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These include

  • A physical examination
  • CT and MRI scan
  • Blood tests

You visit hospital once every 3 weeks to have treatment. You also go to the hospital before each chemotherapy treatment to discuss any side effects with your doctor and have some blood tests.

As you are having cabazitaxel, you have injections with a growth factor drug after each treatment. Growth factors stimulate the bone marrow to make certain blood cells. In this trial you have G-CSF. This is to reduce the chance of infections. You don’t need to go to hospital for this. You or a friend or relative can be taught to give the injection. Or a nurse can visit you at home to give you this drug.

You have a CT scan every 6 weeks until you finish treatment. You see the trial team about 4 weeks after you finish treatment. You will then see them every 3 months for a year. And for a final visit a year after that.

Side effects

The most common side effects of cabazitaxel include

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

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sanofi Aventis
University Hospitals Bristol NHS Foundation Trust

Questions about cancer? Contact our information nurses

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.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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