A trial looking at axitinib for advanced bowel cancer (AXMUS C)
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 axitinib to treat bowel cancer that has spread to another part of the body (advanced bowel cancer).
Doctors can treat advanced bowel cancer with chemotherapy. But sometimes this doesn’t work and the cancer continues to grow. So they are always looking for new treatments.
Axitinib is a type of targeted cancer treatment called a tyrosine kinase inhibitor. The researchers think that axitinib may help people with advanced bowel cancer that has continued to grow despite having chemotherapy.
As a part of this trial, the researchers also want to look at measuring the blood flow to and from the liver using a new type of 
called a contrast enhanced ultrasound.
The aims of the trial are to
- Find out how well axitinib works for people with advanced bowel cancer
- Learn more about the side effects
- Test the contrast enhanced ultrasound
Who can enter
You may be able to enter this trial if
- You have the most common type of bowel cancer (adenocarcinoma) that started in the large bowel (colon) or back passage (rectum)
- Your cancer has spread to your liver or another part of your tummy (
abdomen ) – if it has spread to your liver only, you must have at least 1 area of cancer spread that has not been treated using specialised surgical treatments, such as radiofrequency ablation - You have at least 1 area of cancer spread that can be measured on a scan
- You have had the chemotherapy drugs oxaliplatin, irinotecan and 5FU or capecitabine
- You have had at least 2 different types of chemotherapy for advanced bowel cancer and the cancer has continued to grow, or you stopped treatment because of side effects and there is no other treatment available to you
- You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if
- Your cancer has spread to your brain or the tissue covering your brain or spinal cord
- You have had radiotherapy to the area between your hips (pelvis) in the past 4 weeks – if the radiotherapy was to relieve symptoms you may be able to take part in this trial
- Your cancer spread was diagnosed less than 6 months after you finished the chemotherapy you had after surgery
- You have had surgery in the last 4 weeks
- You are taking another experimental drug as part of a clinical trial
- You still have moderate to severe side effects from any previous treatment
- You have had significant bleeding problems in the last 3 months
- You are taking the blood thinning medication warfarin – unless you are taking 2mg a day or less to prevent blood clots (deep vein thrombosis)
- You have a serious problem in your
abdomen , for example an abnormal opening between 2 parts of your body (fistula) - You have a serious heart problem
- You have high blood pressure that is not controlled by medication
- You have had another cancer in the last 3 years apart from non melanoma skin cancer, very early stage cancer (
in situ carcinoma ) or prostate cancer that has not spread to other parts of the body, is controlled with hormone therapy and there has been no sign of it in the past year - You have pressure on your spinal cord (
spinal cord compression ) - You have serious problems with your
digestive system - You are HIV positive
- You have any other medical condition that could affect you taking part in this trial
- You are taking medication that affects enzymes called CYP3A4 or CYP1A2 – your doctor can confirm this
Trial design
This is a phase 2 trial that will recruit 50 people. 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. And neither of you will know which group you are in either. This is called a double blind trial.
- People in group 1 have axitinib
- People in group 2 have a dummy drug (placebo)
Axitinib and the dummy drug are tablets. You take them twice a day. You can continue treatment as long as it is helping you and the side effects aren’t too bad.
As a part of this trial the researchers also want to try a new type of liver scan called a contrast enhanced ultrasound.
The contrast enhanced ultrasound is similar to having an , but uses a contrast called SonoVue, which is injected into a vein in your arm. The researchers then take an ultrasound scan of your tummy (abdomen) to measure the blood flow to and from your liver.
You have the contrast enhanced ultrasound before you start treatment and then in the 2nd and 8th week of treatment. It takes about 15 minutes each time. You cannot eat or drink for 4 hours before the scan.
If you agree to take part in this trial, the researchers will ask for a sample of tissue taken when you had surgery to remove your cancer. They will also ask for blood samples before starting treatment and then at weeks 2, 4 and 8. If you don’t want to give the tissue sample or the blood samples for this study, you don’t have to. You can still take part in the trial.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Heart trace (
ECG ) - Blood tests
- Urine test
- CT scan
During treatment you see the doctor to have the same tests at 2, 4 and 8 weeks, then monthly. You have a CT scan every 8 weeks.
At the end of treatment you see the doctor and have the same tests again.
Side effects
The most common side effects of axitinib are
- Tiredness (fatigue)
- Diarrhoea or constipation
- Feeling or being sick (nausea)
- Loss of appetite
- High blood pressure
- Changes to your voice
- Sore hands and feet
- Headache
- Cough
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
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
Dr Harpreet Wasan
Supported by
Experimental Cancer Medicine Centre (ECMC)
Imperial College Healthcare NHS Trust
NIHR Clinical Research Network: Cancer
Pfizer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
