A trial looking at cetuximab, irinotecan, oxaliplatin and UFT for advanced bowel cancer (E-SCOUT)

Please note this trial is no longer recruiting patients.

This trial is looking at giving cetuximab, irinotecan, oxaliplatin and UFT to people with bowel cancer that has spread locally, or to other parts of the body (metastatic). We know from research that the combination of irinotecan, oxaliplatin and UFT is good for treating people with advanced bowel cancer.

Doctors usually give irinotecan and oxaliplatin every 2 to 3 weeks. This means you would have both drugs every month. In this trial the researchers want to alternate giving oxaliplatin and irinotecan, so that you have irinotecan one month and oxaliplatin the next month. They believe that this will be just as good as giving both of them every month, but with fewer side effects.

UFT is the capsule form of a drug called 5 fluorouracil (5FU). The National Institute for Health and Clinical Excellence (NICE) has approved UFT as a treatment for advanced bowel cancer.

Cetuximab is a monoclonal antibody. It is already used for people with advanced bowel cancer who have already had chemotherapy. In this trial the researchers will test it in people who have not yet had chemotherapy.

Some bowel cancers have a genetic change called a K-ras mutation. Researchers now know that cetuximab doesn’t help people who have this mutation. So, you will have a test for this and will only have treatment as a part of this trial if you have a normal K-ras gene.

The aim of this trial is to find out if this combination of oxaliplatin, irinotecan, UFT and cetuximab is good for treating advanced bowel cancer, without increasing side effects.

Recruitment

Start 09/04/2009

End 02/05/2012

Phase

Phase 2

Who can enter

You can enter this trial if you

Have the most common type of bowel cancer (adenocarcinoma)
Have advanced bowel cancer
Have bowel cancer that cannot be completely removed with surgery
Have satisfactory blood tests results
Are well enough to take part in this trial (performance status 0-1)
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have bowel cancer with a gene fault called the k-ras mutation
Have bowel cancer that has spread to your brain
Have had chemotherapy for bowel cancer that has spread - you may be able to take part if you had chemotherapy after surgery as long as it finished more than 6 months ago
Have had radiotherapy to the tummy (abdomen) or area between the hips (pelvis) in the past 6 months
Have had drugs that block cancer growth before
Have a completely or partly blocked bowel (bowel obstruction)
Have frequent diarrhoea or inflammatory bowel disease
Have any other medical condition or are taking any medication that could affect you taking part in this trial
Have had another medication as a part of a clinical trial with in the past 4 weeks

Trial design

This trial will recruit 50 people in the UK. Everyone will have cetuximab, irinotecan, oxaliplatin and UFT.

You will have 2 cycles of treatment to start with. If the treatment is working, you may have up to 6 cycles in total. Each cycle of treatment takes 28 days.

On day 1 you have irinotecan and cetuximab. On day 15 you have oxaliplatin and cetuximab. You have all these drugs through a drip into a vein (intravenous infusion).

You have cetuximab first and this takes just over 2 hours. You wait 1 hour and then have irinotecan (day 1) or oxaliplatin (day 15). Irinotecan takes 60 to 90 minutes. Oxaliplatin takes 2 hours.

UFT is a capsule. You start taking UFT on day 1 and continue to take it every day for 21 days. You take the UFT capsules 3 times a day. You have the UFT capsules 1 hour before or after food.

You also take a vitamin (folinic acid) with the UFT capsules. These help the UFT work.

If you take part in this trial, the researchers will ask your permission to take extra blood samples, and samples of tissues from when you had a biopsy. These samples will be stored safely and may be used in the future, but for research purposes only. This is because studying these samples may help researchers learn more about bowel cancer.

If you don’t wish to give these extra samples for research, you don’t have to. You can still take part in the trial.

Hospital visits

You will see the doctor and have some tests before you take part in this trial.

These tests include

Physical examination
Blood tests
CT scan

During treatment every 2 weeks, you will see the doctor and have

Blood tests
Physical examination

You have a CT scan just before the 2nd cycle of chemotherapy, and every 2 months after, to check that the treatment is working.

Side effects

All treatments have side effects. The main side effects of cetuximab, oxaliplatin, irinotecan and UFT are

Tiredness (fatigue)
Feeling or being sick
Rash or itchy skin
Tender finger and toe nails
Loss of appetite
A drop in the blood cells causing an increased risk of infection, bruising and bleeding problems and shortness of breath
Sore mouth
Constipation
Diarrhoea
Hair thinning or loss
Headaches
Sore hands and feet (plantar palmar syndrome)

Oxaliplatin can also make you more sensitive to the cold. This can cause tingling sensations in the hands when you touch cold things or put them in cold water. It can also cause a tight sensation in the throat when you go out in the cold.

There is more about the side effects of cetuximab, irinotecan, oxaliplatin and UFT on the CancerHelp UK website.