A trial looking at BEP chemotherapy for advanced germ cell tumours (UKP3BEP)

Cancer type:

Ovarian cancer
Testicular cancer

Status:

Open

Phase:

Phase 3

This trial is for people with a germ cell tumour that has spread (metastatic). It is for people who have a germ cell tumour of one of the following:

  • ovary
  • testes
  • retro peritoneum - the area at the back of the tummy (abdomen)
  • mediastinum - the area at the centre of the chest which contains the heart, windpipe (trachea) and food pipe (oesophagus)

Cancer Research UK supports this trial.

More about this trial

Chemotherapy is the usual treatment for people with metastatic germ cell tumour.  One treatment is a combination of drugs called BEP. This includes:

  • bleomycin
  • etoposide 
  • cisplatin          

You usually have treatment every 3 weeks. This 3 week period is a cycle of treatment.

You usually also have a drug called G-CSF (granulocyte colony stimulating factor). This is a type of growth factor. It makes the body produce white blood cells Open a glossary item. So the number of white blood cells in the blood are able to return to normal levels more quickly. This reduces the risk of infection after treatment.

Since doctors have started to use G-CSF, they think that people might be able to have chemotherapy more often. So they want to find out if you can have BEP every 2 weeks. This is called accelerated BEP.

Some people in this trial have standard BEP every 3 weeks. Other people have accelerated BEP every 2 weeks. The total dose of your drugs are the same.

The aims of this trial are to: 

  • find out if BEP chemotherapy every 2 weeks improves treatment for people with a germ cell tumour that has spread
  • compare the side effects and quality of life of people who have treatment every 2 weeks and every 3 weeks

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if you have a germ cell tumour of one of the following:

  • ovary
  • testes
  • retro peritoneum - the area at the back of the tummy (abdomen)
  • mediastinum - the area at the centre of the chest which contains the heart, windpipe (trachea) and food pipe (oesophagus)

You must also have one of the following: 

You might be able to take part if your diagnosis has not been confirmed with a biopsy Open a glossary item, but your medical team think you have a germ cell tumour that has spread and they think you should start treatment as soon as possible.

As well as the above, all of the following apply. You

  • Are well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3)
  • Have satisfactory blood test results
  • Are able to start treatment within 2 weeks of joining the trial
  • Are willing to use reliable contraception during treatment and for one year afterwards if there is any chance that you or your partner could become pregnant
  • Are aged between 11 to 45 years old

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

Cancer related

  • Have had chemotherapy or radiotherapy. You might still be able to take part if your cancer has come back following adjuvant Open a glossary item radiotherapy, or 1 or 2 treatments of adjuvant carboplatin for seminoma germ cell tumour. Or you have had low dose chemotherapy for poor prognosis Open a glossary item non seminoma germ cell tumour in preparation for treatment in this trial
  • Have had any other cancer in the last 5 years apart from non melanoma skin cancer that was successfully treated

Medical conditions

  • Have heart disease which means you cannot have intravenous fluids as part of the cisplatin chemotherapy in this trial
  • Have breathing problems which means you cannot have treatment with the chemotherapy drug bleomycin as part of this trial
  • Have problems with numbness and tingling in your hands and feet (peripheral neuropathy) unless this is only mild
  • Have significant hearing loss or tinnitus Open a glossary item
  • Have another illness, such as a serious infection or inflammation of the bladder (cystitis)
  • Are allergic to any of the drugs used in this trial
  • Have any other serious medical condition or mental health problems that the trial team think could affect you taking part

Other

  • Are breastfeeding or pregnant
  • Have had a live vaccine in the last 30 days

Trial design

This is a phase 3 trial. The researchers need 170 people to join in the UK.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor is able to decide which group you are in. 

  • One group has standard BEP chemotherapy (every 3 weeks)
  • The other group has accelerated BEP chemotherapy (every 2 weeks)

UKP3BEP trial diagram

Standard BEP group
You have bleomycin, etoposide and cisplatin through a drip into a vein. You have etoposide and cisplatin every day for the first 5 days. Then no etoposide and cisplatin for the next 16 days.

You start bleomycin on the same day as you start etoposide and cisplatin. You have this once a week for 3 weeks.

Each 3 week period is a cycle of treatment and you have up to 4 cycles.

You have pegfilgrastim or filgrastim on the sixth day of every cycle. These are types of G-CSF (granulocyte colony stimulating factor).

You have pegfilgrastim or filgrastim in one of the following ways:

  • as an injection into your vein
  • into the top layer of tissue just under your skin (subcutaneously)

You have these injections every day until blood tests show that the number of white blood cells in your blood are back to normal.  

Accelerated BEP group
As in the standard group, you have your drugs through a drip into a vein. You have etoposide and cisplatin every day for the first 5 days. Then no etoposide and cisplatin for the next 9 days.

You start bleomycin on the same day as you start etoposide and cisplatin. You have this once a week for 2 weeks.

Each 2 week period is a cycle of treatment and you have up to 4 cycles of BEP.

After 4 cycles of accelerated BEP you have bleomycin every week for a further 4 weeks.

You have pegfilgrastim or filgrastim as described in the standard group. You start these injections on the sixth day of each cycle. You have them until the number of white blood cells in your blood are back to normal.

VIP treatment
You might change to a different treatment if doctors find that BEP is causing damage to your lungs. If this is the case, you have a combination of drugs called VIP (also called PEI) which includes:

  • etoposide
  • cisplatin
  • ifosfamide and mesna

Like BEP, this treatment is also standard treatment for people with a germ cell tumour. You have all of these drugs through a drip into a vein. You have them every day for the first 5 days of each 3 week cycle. You also have injections of pegfilgrastim or filgrastim.

You are still part of the trial if you change to VIP treatment. How many cycles of VIP you have depends of how many cycles of BEP you have had. You have 4 cycles of treatment in total.

Quality of life 
The trial team ask you to fill out a questionnaire:

  • at the beginning of each cycle of treatment
  • about 4 to 6 weeks after finishing treatment
  • 6,9,12 and 18 months after finishing treatment 

These questionnaire ask about side effects and how you’ve been feeling.  The researchers use these to find out more about your quality of life. 

Extra blood and tissue samples
If you agree, you have extra blood samples taken as part of this trial. You have 6 extra samples taken before, during and after treatment. Where possible you have these at the same time as your routine blood tests.

The researchers would also like a sample of your cancer if you have an operation to remove your germ cell tumour.

These samples are stored and used in future research. For example, researchers might look at them to try to find out why some cancers respond to chemotherapy and some don’t.

Providing these samples is optional. You don’t have to agree to this if you don’t want to. You can still take part in the trial.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include:

  • physical examination
  • tests to measure your blood pressure, heart rate and temperature
  • chest x-ray
  • blood tests
  • CT scan of your body

Depending on your situation, you might also have

  • hearing tests
  • tests to check that your kidneys are working normally
  • tests to check that your lungs are working normally (lung function tests Open a glossary item)
  • bone scan
  • MRI scan or CT scan of your brain

You go to hospital every day for the first 6 days of each cycle of treatment. Then every week for the remaining week or 2 weeks of each cycle, depending on which group you are in.

You are in hospital for about 5 to 6 hours on the days you have etoposide and cisplatin. Your time in hospital should be shorter (1 to 2 hours) on the days you have bleomycin.

At the beginning of each cycle you see a doctor and have blood tests and a chest x-ray. Your chest is examined by a doctor before each treatment of bleomycin. For example, they listen to your breathing with a stethoscope. You have 1 additional chest x-ray on the day you start your bleomycin only treatment if you are in the accelerated BEP group.

Your doctor will discuss further treatment with you once you have finished your chemotherapy. You might have surgery to remove any remaining tumour. Or you might have more chemotherapy.

Once your treatment in the trial has finished you have further appointments about:

  • 4 to 6 weeks after your last chemotherapy treatment
  • 6 months after starting the trial

 Then every:

  • 3 months for 2 years
  • 6 months for the following 3 years

You have blood tests and you might have a CT scan. You have other tests if your doctor thinks you need them.

Side effects

The most common side effects of BEP chemotherapy include:

We have more information about BEP chemotherapy.

The side effects of VIP chemotherapy are similar to BEP because they both include the drugs cisplatin and etoposide. VIP uses ifosfamide instead of bleomycin and so inflammation of the lung is not a common side effect. The common side effects of VIP also include:

  • dizziness
  • flushing
  • flu like symptoms
  • irritation of the bladder causing you to pass urine frequently and sometimes blood in the urine
  • kidney damage

We have more information about VIP chemotherapy, also called PEI or IPE.

Location

Cambridge

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 Danish Mazhar

Supported by

Cancer Research UK
Cambridge University Hospitals NHS Foundation Trust

Other information

This is Cancer Research UK trial number CRUK/14/045.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14699

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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