
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
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.
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 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
You can enter this trial if you
You cannot enter this trial if you
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.
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
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
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Prof Nick Reed
Bristol-Myers Squibb
Experimental Cancer Medicine Centre (ECMC)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”