A trial looking at AEZS 108 for advanced womb cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a new drug called AEZS 108 to treat womb (endometrial) cancer.
If womb cancer has spread to other parts of the body, or has come back after it was first treated, it is called advanced womb cancer. Doctors can use treatments such as chemotherapy for advanced womb cancer. One chemotherapy drug they use is called doxorubicin.
AEZS 108 has 2 parts. One part is doxorubicin. The other is a type of 
. The hormone helps doxorubicin attach to the cancer cells using certain hormone receptors.
The main aim of this trial is to compare AEZS 108 with doxorubicin to find out which helps women with advanced womb cancer live longer.
Who can enter
You may be able to join this trial if all of the following apply.
- You have womb cancer that is mainly a type called adenocarcinoma
- Your cancer has spread to your vagina, ovaries or lymph glands (stage 3) or to another part of your body (stage 4) or has come back after treatment
- You have had only 1 type of chemotherapy for your womb cancer (or 1 type since your womb cancer came back)
- Your chemotherapy included a
platinum drug or a taxane drug (your doctor can tell you this) - You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you could become pregnant
- You have satisfactory blood test results
- You are at least 18 years old
You cannot join this trial if any of these apply.
- Your cancer has spread to your brain or the tissues surrounding the brain
- You have had a chemotherapy drug called an
anthracycline (your doctor can tell you this) - You had any anti cancer treatment in the past month
- You have had a
blood transfusion of red blood cells in the past 2 weeks - You have had a heart attack or chest pain in the past 6 months
- You have an irregular heart beat that isn’t controlled with medication
- You have another serious heart problem
- Your heart doesn’t work well enough (your doctor will test for this)
- Your doctor plans to start you on medication that can affect the way your heart works (ask your doctor about this)
- You have taken a type of
hormone therapy called an LH blocker in the past 6 months (your doctor can tell you about this) - You have already had AEZS 108
- You are sensitive to the drugs used in this trial or any of their ingredients
- You have had another cancer in the past 5 years apart from non melanoma skin cancer
- You are taking an experimental drug as part of another clinical trial
- You have any other medical condition that could affect you taking part in this trial
- You are pregnant or breastfeeding
Trial design
This is an international phase 3 trial. The researchers need 500 people to join the trial.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
- People in group 1 will have AEZS 108
- People in group 2 will have doxorubicin
You have AEZS 108 as an injection into a vein. You also have drugs to stop you feeling or being sick. You have treatment every 3 weeks. It takes 2 hours. You can have up to 9 treatments as long as the side effects aren’t too bad and it is helping you.
You have doxorubicin as an injection into a vein. It takes an hour. Your doctor will talk to you about how many treatments of doxorubicin you can have.
To take part in this trial, you must agree to give a sample of your cancer that was removed when you had surgery or a . If this isn’t available they will take a small piece of cancer tissue (biopsy) when you agree to take part in the trial.
The trial team will ask you to fill out a questionnaire before you start treatment, twice during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - Heart scan (
ECHO or MUGA ) - CT scan or MRI scan
- Bone scan if needed
During treatment you see the doctor once a week for the first 3 weeks and then every 3 weeks afterwards. You have a heart scan at 9 and 18 weeks and at the end of treatment. You have a scan every 9 weeks.
After treatment you see the doctor every 3 months until your cancer gets worse.
Side effects
The most common side effects of AEZS 108 include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Loss of strength and energy
- Tiredness
- Hair loss
- Weight loss
- Mouth ulcers
- Sore throat
- Loss of appetite
Hot flushes - Difficulty swallowing
- Itching
We have information on the side effects of doxorubicin.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Hani Gabra
Supported by
Aeterna Zentaris Inc
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
