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:

Bowel (colorectal) cancer

Colon cancer

Rectal cancer

Status:

Closed

Phase:

Phase 2

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 biological therapy. It works by targeting a protein called vascular endothelial growth factor (VEGF). 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 ultrasound scan Open a glossary item 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)

Axmus C trial diagram

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 ultrasound Open a glossary item , 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.