A trial comparing BEP and Taxol-BEP chemotherapy for male germ cell tumours (MRC TE21, EORTC 30983)

This trial is looking at BEP chemotherapy with or without Taxol for male germ cell tumours.

Germ cells are the cells that produce eggs in females and sperm in males. Male germ cell cancers usually develop in the testicles, but can be found in other parts of the body.

Doctors often treat germ cell cancers with surgery if it is in the testicle, or chemotherapy if it is somewhere else in the body. They usually give a combination of chemotherapy called BEP. This is bleomycin, etoposide and cisplatin.

BEP often works very well. But doctors are always keen to improve treatments. They think that adding a drug called paclitaxel (Taxol) may be better for germ cell tumours classed as ‘intermediate prognosis’. There are two main types of germ cell tumour. Intermediate prognosis for seminoma germ cell tumour means that the tumour has spread beyond the lung and lymph nodes. Intermediate prognosis for non seminoma germ cell tumours means that the tumour started in your testicle or abdomen. It may have spread to the lungs or lymph nodes, but no further. The markers in the blood are also moderately raised.

Paclitaxel is a drug that is sometimes used after other treatments such as BEP, or for more advanced germ cell tumours. Doctors do not currently use it at the same time as BEP, or for this group of patients.

The aim of this trial is to compare BEP with Taxol-BEP (T-BEP) to see which is better for intermediate prognosis germ cell tumours and to find out more about the side effects of this combination of treatment. All drugs have some side effects. It is important to test new treatments like this so that people do not have drugs they don’t need.

Please note this trial is no longer recruiting patients.

Recruitment

Start 01/10/1998

End 25/08/2009

Phase

Phase 3

Who can enter

You can enter this trial if you

Have seminoma germ cell cancer that has spread beyond your lung and lymph nodes or non seminoma germ cell cancer with moderately raised blood markers (both these situations are ‘ intermediate prognosis germ cell tumours’)
Are well enough for chemotherapy (performance status 0,1 or 2)
Have satisfactory blood test results
Are a man aged between 16 and 50 years old

You cannot enter this trial if you have

Had chemotherapy before
Had any other cancer (apart from basal cell skin cancer)
Poor kidney or liver function
Any other serious medical condition

Trial design

This is a randomised trial. It will recruit 500 people into 2 groups. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Group 1 have BEP chemotherapy. You have cisplatin and etoposide through a drip into a vein every day for 5 days, every 3 weeks. Cisplatin takes about 4 hours and etoposide takes about an hour. You have bleomycin through a drip into a vein once a week. This takes about half an hour. Each 3 weeks of treatment is one cycle. You have 4 cycles over 3 months altogether.

Group 2 have T-BEP chemotherapy. You have BEP as described above for group 1. You also have paclitaxel (Taxol) through a drip into a vein once every 3 weeks. This takes about 3 hours each time. Each 3 weeks of treatment is one cycle. You have 4 cycles over 3 months altogether.

If you are in group 2, you will also have an injection of a growth factor just under the skin (subcutaneous injection), daily for 10 days every 3 weeks (days 6 to 15). Chemotherapy can cause the number of blood cells to fall, and the growth factor (called G-CSF) can help to stop this happening.

You will fill out a questionnaire when you join the trial (before you start treatment), and another one at 1 year and 2 years. It will ask you how you have been feeling and about any side effects you have had. This is called a quality of life questionnaire.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. The tests include

Blood tests
Physical examination
Urine tests
Chest X-ray
CT scan
Hearing test
Lung function tests

Every 3 weeks, you will stay in hospital for 6 days to have cisplatin and etoposide (and Taxol if you are in group 2). You will have bleomycin once a week as an out patient on the weeks in between.

If you are in group 2, you don’t need to go to hospital to have your growth factor injections. The nurses will teach you (or a family member) how to do this at home.

You will see the doctors and have a physical examination and chest X-ray before each cycle of treatment. You will have blood tests once a week while you are having treatment.

After you finish treatment you will have blood tests, a hearing test, a CT scan and lung function tests. You will then see the doctors

Every month for a year, then
Every 2 months for year 2, then
Every 3 months for year 3, then
Every 6 months for year 4, then
Once a year after that

You will have a CT scan every 3 to 6 months for a year, and then every 6 to 12 months for 2 years. How often you have a scan will depend on the results of the scan before.

Side effects

The most common side effects of BEP are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
Feeling or being sick
Hair loss
Sore mouth
Inflammation in the lungs with bleomycin
Fever and chills with bleomycin
Reduced kidney function with cisplatin (you will have lots of fluids to stop this happening)
Reduced hearing of high pitched sounds with cisplatin

The most common side effects of Taxol are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
Numbness and tingling in hands and feet (peripheral neuropathy)
Hair loss
Feeling or being sick
Sore mouth
Diarrhoea

There is more information on the following links about the side effects of