A study of M6620 for cancer of the food pipe (oesophagus) and other solid tumours (CHARIOT)

Cancer type:

All cancer types
Oesophageal cancer

Status:

Open

Phase:

Phase 1
This study is looking at M6620 with chemotherapy and, or radiotherapy for oesophageal cancer and other solid tumours. 
 
A solid tumour is any cancer apart from blood cancers such as:
  • leukaemia Open a glossary item 
  • lymphoma Open a glossary item 
  • myeloma Open a glossary item 
Cancer Research UK supports this study. 

More about this trial

M6620 is a targeted cancer drug. It works by blocking signals that tell damaged cancer cells to repair themselves. 
 
We know from other studies that M6620 could help people with cancer. 
 
Treatment for oesophageal cancer for people who can’t have or don’t want surgery is usually:
  • chemotherapy
  • radiotherapy 
  • a combination of chemotherapy and radiotherapy (chemoradiation)
In this study the team want to find the best dose of M6620 to give with these treatments. They also want to find how often to give M6620. 
 
Other aims of this study are to find out how well M6620 works and more about the side effects.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
 
There are 3 parts in this study. 
 
To take part in any stage of the study
 
You may be able to join any part of the study if all of the following apply. You:
  • have satisfactory blood test results
  • can do everything apart from heavy physical work (performance status 0 or 1)
  • are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
  • are at least 16 years old
To take part in stage A1 
 
You may be able to join stage A1 of the study if all of the following apply. You:
  • have oesophageal cancer that is an adenocarcinoma or a squamous cell carcinoma 
  • have cancer in the middle or lower part of the oesophagus 
  • have cancer that is 10cm or less in length
  • are suitable to have radiotherapy to control symptoms (palliative radiotherapy) and aren’t suitable to have chemoradiation or surgery with the aim to cure your cancer 
To take part in stage A2
 
You may be able to join stage A2 of the study if all of the following apply. You:
  • have any solid tumour that has spread to another part of the body or can’t be removed by surgery
  • can have cisplatin and capecitabine to treat your cancer
To take part in stage B
 
You may be able to join stage B of the study if all of the following apply. You:
  • have oesophageal cancer in the middle or lower part of the oesophagus that is an adenocarcinoma or a squamous cell carcinoma and is 7 cm or less in length ​or you have a gastro oesophageal junction cancer  Open a glossary itemthat is type 1 or type 2 and is 2cm or less in length 
  • can have chemoradiation and aren’t suitable for surgery or choose not to have surgery
  • have tests that show your lungs and heart work well enough to have chemoradiation 
Who can’t take part
 
You cannot join this study if any of these apply. You:
  • have cancer that has spread to the brain
  • have gastro oesophageal junction cancer that has a large amount of the HER2 protein Open a glossary item  where anti HER2 treatment is more suitable, unless you have had this treatment and it has failed (in this case you might be able to join stage A1 and A2)
  • have another cancer apart from carcinoma in situ Open a glossary item of the cervix that has been removed by cone biopsy or successfully treated non melanoma of the skin Open a glossary item
  • have had a serious heart problem such as a heart attack, congestive heart failure or unstable angina in the past 6 months
  • have problems with your heart beat such as irregular heart beat or very fast heart beat that needs treatment 
  • have any other serious heart problem 
  • have high blood pressure that is not controlled by medication
  • have an abnormal opening (fistula) between your breathing tube (trachea) and your food pipe (oesophagus) 
  • have cancer that has grown from your food pipe into your breathing tube
  • have taken part in another clinical trial in the past month
  • have had medications that affect the CYP3A enzyme within 2 weeks of starting M6620
  • have had medication that helps your body to increase the number of blood cells (blood cell growth factors Open a glossary item)
  • are taking warfarin and are unable to or unwilling to change to using heparin
  • have HIV, hepatitis B or hepatitis C
  • have any other medical or mental health condition that your doctor or the study team think could affect you taking part
  • are pregnant or breastfeeding
You can’t take part in stage A1 
 
If any of the following apply. You:
  • have had radiotherapy to the chest or the upper part of the tummy (abdomen)
  • have a tube (a stent) in your food pipe to keep it open and stop it from blocking 

You can’t take part in stage A2

If any of the following apply. You:
  • have had hand and foot syndrome Open a glossary item
  • have problems with your hearing
  • have had a live vaccine  Open a glossary itemwithin 30 days of starting M6620
You can’t take part in stage B
 
If any of the following apply. You:
  • have already had chemotherapy
  • have a tube (a stent) in your food pipe to keep it open and stop it from blocking 
  • have had hand and foot syndrome
  • have problems with your hearing
  • have had a live vaccine within 30 days of starting M6620

Trial design

This is a phase 1 study. There are 3 stages to the study. Everyone will have M6620.
 
The study team want to find the best dose, and how often, to give M6620 with:
  • radiotherapy (stage A1)
  • cisplatin and capecitabine (stage A2)
  • chemoradiation (stage B)
The dose and how often you have M6620 will vary depending on when you agree to join the study. But the dose of M6620 and how often you have M6620 will stay the same while you are taking part of the study. 
 
Stage A1 
In stage A1 the team need up to 20 people to join. 
 
You have radiotherapy once a day, Monday to Friday, for 3 weeks. You have M6620 an hour after having radiotherapy. 
 
You have M6620 as a drip into a vein. You have it over 1 hour to 1½ hours. Your doctor will tell you how often you are to have M6620. This will be either once or twice a week. 


Stage A2 

In stage A2 the team need up to 20 people to join.

You have cisplatin as a drip into a vein. You have it over 2 hours. You have it once every 3 weeks. Each 3 week period is called a cycle of treatment. You have up to 6 cycles of cisplatin. 

Capecitabine is a tablet. You take it twice a day during the cycles of cisplatin treatment. You take capecitabine within 30 minutes after eating. Your doctor will tell you how many tablets you must take. 

You have M6620 once or twice each week. You have M6620 as a drip into a vein. It takes between 1 and 1½ hours. Your doctor will tell you how often you are to have M6620. This will be either once or twice a week. 


Stage B 

In stage B the team need up to 25 people to join. 

You have treatment with cisplatin and M6620 every 3 weeks. Each 3 week period is called a cycle of treatment.

Before starting radiotherapy, you have 2 cycles of treatment with cisplatin and M6620. You have cisplatin at the start of each cycle. 

You have M6620 the day after you have cisplatin (2nd day of the treatment cycle). How often you have M6620 will depend on when you agree to join the study. 

You take capecitabine twice a day every day during the first 2 cycles of treatment of cisplatin. You take capecitabine within 30 minutes after eating. Your doctor will tell you how many tablets you must take. 

You have radiotherapy Monday to Friday for 5 weeks. During radiotherapy you have cisplatin at the start of each 3 week period of treatment (a cycle of treatment). 

You have M6220 an hour after radiotherapy on the 2nd day of each cycle. This may be more regular depending on when you join the study. 

When you start radiotherapy, you take capecitabine twice a day on the days you have radiotherapy, Monday to Friday. You don’t take capecitabine on Saturday or Sunday.


You have a diary card to record when you have your capecitabine. You must bring this to every hospital visit for the doctor to see. 

Blood and tissue samples
People in stage A2 and stage B will have extra blood samples taken. 

The study team will use these blood samples to understand how M6620 affects your body and the cancer cells. 

People in stage B will also have 2 extra samples of tissue taken from their cancer. The team will use these to find out how M6620 affects the cancer cells.

When you agree to join stage A2 or stage B you must also agree to have these blood and tissue samples taken. 

Hospital visits

You see the doctor to have some tests before taking part in the study. These tests include:
  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan
People in stage A2 and stage B may also have a hearing test, if needed. 
 
During treatment you see the doctor regularly to see how you are. 
 
If you are in stage A2 you have a CT scan every 6 weeks during treatment.
 
Stage A1
You see the doctor after treatment at:
  • 1 week
  • 6 weeks
  • 9 weeks 
You have:
  • a physical examination
  • blood tests
  • heart trace at week 4 and week 12
  • CT scan at week 12
Stage A2
You see the doctor 2 weeks and 8 weeks after treatment for a physical examination and blood tests.
 
You have a CT scan 8 weeks after treatment. 
 
Stage B
You see the doctor 1 week after finishing treatment then at 7 weeks and 13 weeks. You have a physical examination and blood tests. You have a CT scan and heart trace at 12 weeks. Another sample of cancer tissue (biopsy) is taken at 12 weeks. 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse
  • you notice anything unusual or anything that has changed
M6620 is a new drug and there might be side effects we don’t know about yet. The most common reported side effects include:
The most common side effects of having radiotherapy to the food pipe (oesophagus) include:
  • tiredness
  • sore inflamed oesophagus causing pain or difficulty swallowing
  • feeling or being sick
  • shortness of breath
  • a change to the way the heart works
  • changes in skin colour
We have information about the side effects of cisplatin and capecitabine.

Location

Cardiff
Glasgow
Manchester
Oxford

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Maria Hawkins

Supported by

Cancer Research UK
CRUK/MRC Oxford Institute for Radiation Oncology
Experimental Cancer Medicine Centre (ECMC)
Merck KGaA
University of Oxford

 

 

Other information

This is Cancer Research UK trial number CRUKD/15/011.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14312

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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