A trial looking at chemotherapy for male germ cell cancer (TE 23)

Please note this trial is no longer recruiting patients.

This trial is comparing 2 different chemotherapy regimes for male germ cell cancers.

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 usually 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 doesn’t always work well for germ cell cancers that are classed as ‘poor prognosis’. Doctors think a new combination of drugs known as CBOP BEP may work better for these cancers. CBOP BEP is carboplatin, vincristine, bleomycin, etoposide and cisplatin. But all chemotherapy drugs have some side effects, and it is important that patients don’t have treatments they don’t need.

The aim of this trial is to compare BEP and CBOP BEP to see which works better for poor prognosis male germ cell cancer. And to find out more about the side effects.

Recruitment

Start 01/06/2005

End 14/12/2009

Phase

Phase 2

Who can enter

You can enter this trial if you

Have germ cell cancer that the doctors class as ‘poor prognosis’
Are well enough for chemotherapy (performance status 0, 1 or 2)
Have satisfactory blood test results
Are male and aged 16 or over
Are prepared to use reliable contraception if there is a chance that your partner could become pregnant

You cannot enter this trial if you have

Had chemotherapy before
Any other serious medical condition

Trial design

This is a randomised trial. It will recruit 88 patients into 2 groups. The men taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1 you will have BEP chemotherapy. You have etoposide and cisplatin daily, for 5 days every 3 weeks. And bleomycin once a week. Each 3 week block is one cycle of chemotherapy. You will have 4 cycles over 12 weeks (3 months).

If you are in group 2 you will have CBOP BEP chemotherapy. You will have treatment for 15 weeks (nearly 4 months) altogether. During the first 4 weeks you have CBOP (carboplatin, bleomycin, vincristine and cisplatin). During weeks 5 and 6 you have BO (bleomycin and vincristine). And during weeks 7 to 15 you have BEP (bleomycin etoposide and cisplatin). Your doctor will explain the exact order of the drugs you will have nearer the time.

Hospital visits

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

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

You will go to hospital to have chemotherapy. You will need to stay in hospital for part of your treatment. But how often and for how long will depend on which group you are in.

You will have blood tests, a physical examination and a chest X-ray every few weeks before each cycle of chemotherapy. At the end of treatment you have a CT scan, physical examination and some blood tests.

After you finish treatment you will see the doctors every 2 months for a year, every 3 months for another year, and then every 6 months for 3 years. You will have a physical examination, blood tests and a chest X-ray at each visit. You will also have CT scans, but exactly when will depend on the usual practice at your hospital. You will have hearing tests and lung function tests at 1 year.

Side effects

The most common side effects of the drugs used in this trial 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
Numbness and tingling in hands and feet (peripheral neuropathy) with vincristine
Stomach pain and constipation with vincristine