A trial looking at ixabepilone, paclitaxel and doxorubicin for advanced cancer of the womb lining (endometrial cancer) (CA163196)

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 a drug called ixabepilone with either paclitaxel or doxorubicin for womb cancer that has come back or spread to another part of the body after treatment with chemotherapy.

Cancer of the womb lining is also called endometrial cancer, but is often just called womb cancer because it is the most common type of cancer of the womb.

Doctors usually treat womb cancer with surgery. But if the cancer is advanced Open a glossary item when it is diagnosed, or comes back after surgery, you may have chemotherapy. Drugs that doctors use include carboplatin, paclitaxel, cisplatin and doxorubicin. If womb cancer comes back or continues to grow after having one type of chemotherapy, doctors are not sure of the best way to treat it. So researchers are trying to find treatments to help women in this situation.

In this trial, they are looking at a chemotherapy drug called ixabepilone. Some women will have ixabepilone, some will have either paclitaxel or doxorubicin.

The aims of the trial are to

See if ixabepilone works better than doxorubicin or paclitaxel for advanced womb cancer that has come back or continued to grow after chemotherapy
Learn more about the side effects of these treatments

Who can enter

You can enter this trial if you

Have been diagnosed with womb (endometrial) cancer
Have cancer that has grown into surrounding body tissue or has spread to another part of the body
Have cancer that has come back or continued to grow after having one type of chemotherapy that included a platinum drug and your doctors don’t think it can be cured with surgery or radiotherapy
Are well enough to take part (Karnofsky performance status of at least 70)
Have satisfactory blood test results
Are willing to use reliable contraception during the trial and for 4 weeks after if you have not had surgery to remove your womb and there is any chance that you could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have sarcoma of the womb
Have cancer that has spread to your brain
Have not already had one other type of chemotherapy for advanced womb cancer
Have had more than one type of chemotherapy for advanced womb cancer – you can take part if you had another course of chemotherapy to try to stop the cancer coming back before or after your surgery
Have had any other type of cancer in the last 5 years apart from non melanoma skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast (DCIS or LCIS) as long as you didn’t have chemotherapy treatment
Have had hormone therapy for womb cancer in the last week or any other treatment for womb cancer in the last 3 weeks
Are currently having any other cancer treatment or another experimental drug
Have already had treatment with ixabepilone
Are allergic to any of the drugs in the trial
Take any other drugs that affect an enzyme called CYP3A4 (your doctor can advise you about this)
Have any sort of nerve damage (unless it is very mild)
Have an infection that needs treatment with antibiotics or any other serious medical condition that could affect you taking part in this trial
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is an international trial that will recruit 500 women in different countries around the world. It is a randomised trial. The women taking part will be put into 1 of 2 treatment groups by a computer. Neither you nor you doctor can decide which group you are in.

You have treatment through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment.

Women in group 1 have ixabepilone which takes 3 hours each time
Women in group 2 have either doxorubicin which takes up to half an hour each time, or paclitaxel which takes about 3 hours each time

If you are in group 2 and have already had treatment with doxorubicin, you will have paclitaxel.

If it is not causing any serious side effects, you can carry on having the trial treatment for as long as it helps you. But if you have doxorubicin, there is a limit to how much of this drug you can have. When you reach this limit, the trial doctor will talk to you about your treatment options.

You will be asked to fill out a questionnaire before you start treatment, every 6 weeks during treatment and after you finish treatment. The questionnaire will ask about any side effects you have and how you are feeling. This is called a quality of life study.

Hospital visits

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

Physical examination
Blood tests
Urine tests
Heart trace (ECG )
Heart scan (echocardiogram )
CT scan or MRI scan

You go to hospital once every 3 weeks to have treatment. During the first 3 cycles of treatment, you have blood tests every week. After that you just have a blood test on the day you have treatment, or within 3 days of treatment. You have a scan every 6 weeks. If you have doxorubicin, you will have more heart scans starting after the 4th cycle of treatment.

If you stop having the trial treatment because your cancer gets worse, the trial team will ask you to have one more scan. If you stop the trial treatment for any other reason, they will ask you to have a scan every 6 weeks for the next year and every 3 months after that.

After you finish treatment, the trial team will ask if they can contact you every 3 months to check how you are and to ask about any other cancer treatment you may be having.

Side effects

As ixabepilone is still quite a new drug, there may be some side effects that doctors don’t know about yet. In trials so far, side effects have included

Hair loss
Weakness or tiredness (fatigue)
A drop in the number of blood cells causing an increased risk of infection, tiredness or shortness of breath
Sickness
Tummy (abdominal) cramps
Diarrhoea or constipation
Numbness or tingling in the limbs

Occasionally, ixabepilone or paclitaxel can cause an allergic reaction. If you are having either of these drugs, you will have medicine beforehand to try to stop this happening.

There is more information about the side effects of paclitaxel and doxorubicin on CancerHelp UK.