A trial looking at doxorubicin (Adriamycin) and cisplatin with or without paclitaxel (Taxol) for women with advanced womb (endometrial) cancer (EORTC 55984)

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

Cancer type:

Womb (uterine or endometrial) cancer

Status:

Closed

Phase:

Phase 3

This trial is comparing 2 different chemotherapy regimes for advanced womb cancer.

Womb (endometrial) cancer can often be treated successfully with surgery. But sometimes the cancer comes back after initial treatment, or it is advanced Open a glossary item when first diagnosed.

One of the treatments for women with advanced womb cancer is chemotherapy. Previous trials have shown that doxorubicin (Adriamycin) and cisplatin can work well together. This trial is trying to find out if adding another chemotherapy drug called paclitaxel (Taxol) will mean that the cancer is less likely to come back. The trial will compare these two groups of drugs

Doxorubicin (Adriamycin) and cisplatin
Doxorubicin (Adriamycin), cisplatin and paclitaxel (Taxol)

The researchers will also look at how the different combinations of drugs will affect quality of life.

Who can enter

You can enter this trial if you

Have advanced womb (endometrial) cancer OR
Have womb (endometrial) cancer that has spread to another part of your body OR
Have womb cancer that cannot be removed with surgery
Are well enough to have chemotherapy
Have satisfactory blood tests
Are at least 18 years of age

You cannot enter this trial if you

Have a type of womb cancer called mixed mesodermal, sarcoma or uterine papillary serous carcinoma (UPSC)
Have had radiotherapy to your pelvis in the past
Have had chemotherapy in the past
Have had hormone therapy in the last 4 weeks
Have had another cancer in the last 5 years (apart from non melanoma skin cancer or carcinoma in situ of the cervix)
Are pregnant or breastfeeding
Have an active infection
Cannot tolerate high dose dexamethasone (a type of steroid )

Trial design

This European trial will recruit 300 patients. The trial is randomised and there are two treatment groups. The people taking part are put into the different 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 doxorubicin (Adriamycin) and cisplatin chemotherapy. You will have these drugs, as well as anti sickness drugs, through a drip into a vein in your arm. This will take about 2 hours. You will also have fluids through your drip before and after your treatment. This is one cycle of treatment, which is repeated every 3 weeks. You will have 6 cycles in total, so your treatment will take about 3 and a half months overall.

If you are in group 2, you will have doxorubicin (Adriamycin), cisplatin and pacitaxel (Taxol) chemotherapy. You will have these drugs, as well as anti sickness drugs, through a drip into a vein in your arm. This will take about 6 hours.

Before your chemotherapy you will have a steroid Open a glossary item (dexamethasone) and anti histamine drug through the drip. This is to try to prevent possible side effects caused by paclitaxel (Taxol). You will also have fluids through your drip before and after your treatment. This is one cycle of treatment, which is repeated every 3 weeks. You will have 6 cycles in total, so your treatment will take about 3 and a half months overall.

Hospital visits

Before you start your treatment a doctor will examine you and do various tests. These will include

Blood tests
Chest X-ray
ECG
CT or MRI scan of your cancer.

You will have blood tests before each cycle of chemotherapy. The scan, chest x-ray and ECG Open a glossary item will be repeated after the third and sixth cycle.

After your treatment finishes, you will continue to see a doctor

Every 3 months for the first 2 years
Every 6 months for the next 3 years
Every year after that

You will be examined by a doctor and some of the above tests will be repeated.

You will also fill out a questionnaire that will take about 10 minutes. This will ask how you have been feeling. It is called a ‘quality of life’ study. You complete these questionnaires before your treatment, after the 3rd cycle, 6th cycle and then every 6 months.

Side effects

All chemotherapy drugs have possible side effects. You can find out more about the side effects of doxorubicin (Adriamycin), cisplatin and paclitaxel (Taxol) on CancerHelp UK.

The most common side effects of these drugs are

A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Feeling or being sick
Hair loss
Loss of appetite
Dry and sore mouth
Temporary aching in muscles and joints
Numbness or tingling in hands and feet