Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
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.
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.
Doctors usually treat womb cancer with surgery. But if the cancer is
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 drugand 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
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.
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 (
- Heart scan (
- 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.
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
- 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.
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.
Prof Nick Reed
Experimental Cancer Medicine Centre (ECMC)