A trial looking at BEP chemotherapy for advanced germ cell tumours (UKP3BEP)
Cancer type:
Status:
Phase:
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. 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:
- non seminoma testicular cancer that is intermediate and poor risk (your doctor can tell you what risk group your cancer is)
- seminoma testicular cancer that is intermediate risk
- stage 4 ovarian germ cell tumour (including choriocarcinoma, embryonal carcinoma, mixed malignant germ cell tumour and germ cell tumour of the yolk sac)
You might be able to take part if your diagnosis has not been confirmed with a biopsy, 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 radiotherapy, or 1 or 2 treatments of adjuvant carboplatin for seminoma germ cell tumour. Or you have had low dose chemotherapy for poor prognosis non seminoma germ cell tumour or stage 4 ovarian 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
- 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 110 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)
Standard BEP group
You have etoposide and cisplatin through a drip into a vein. You have bleomycin as an injection into a muscle (intramuscular injection), or through a drip into your vein. You usually have the intramusular injection in your buttocks or upper thigh.
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 etoposide and cisplatin through a drip into a vein. You have bleomycin as an injection into a muscle (intramuscular injection), or through a drip into your 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)
- 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:
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- cough
- loss of appetite
- feeling or being sick
- diarrhoea
- constipation
- bone and muscle pain
- hair loss
- numbness and tingling in your hands and feet (peripheral neuropathy)
- skin rash, discolouration and hard parches on the skin
- changes to the way your liver and kidneys work
- inflammation of the lungs causing a cough and difficulty breathing
If you have bleomycin as an injection in your muscle, you might have some pain, swelling, tenderness and redness at the site of the injection.
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
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.
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.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Last reviewed:
Dangoor Education since 2010.
