A trial looking at cetuximab, capecitabine and irinotecan with radiotherapy before surgery for cancer of the rectum (EXCITE)

Please note this trial is no longer recruiting patients.

This trial is looking at having cetuximab (Erbitux), capecitabine (Xeloda) and irinotecan (Campto) with radiotherapy before surgery for rectal cancer that has spread into the surrounding tissues.

Doctors often use radiotherapy to shrink rectal cancer before surgery. You may have chemotherapy at the same time. This is called chemoradiation. As well as killing some cancer cells, some chemotherapy drugs can make cancer cells more sensitive to radiotherapy. Having chemotherapy with radiotherapy is often better at shrinking a cancer than radiotherapy alone.

Capecitabine is a chemotherapy drug doctors often use in chemoradiation for rectal cancer. Irinotecan is another chemotherapy drug that is used for bowel cancer. We know from research that using irinotecan and capecitabine together may work better than capecitabine alone.

Cetuximab is a type of biological therapy. We know from research that cetuximab can help radiotherapy work.

In this trial, everybody will have cetuximab, irinotecan, capecitabine and radiotherapy. The aims of the trial are to find out

How much this treatment helps to shrink rectal cancer
What the side effects are

Recruitment

Start 09/04/2009

End 24/10/2011

Phase

Phase 2

Who can enter

You can enter this trial if you

Have type of rectal cancer called adenocarcinoma that has spread outside the rectum into the surrounding tissues
Are able to have surgery (your doctor can advise you about this)
Are able to have radiotherapy (your doctor can advise you about this)
Are well enough for treatment (performance status 0 or 1)
Have satisfactory blood test results
Are willing to use reliable contraception if there is a chance that you or your partner could become pregnant

You cannot enter this trial if you

Have rectal cancer that has spread to other parts of the body
Have cancer that is close to the anus
Have a blockage in the rectum (rectal obstruction)
Have already had chemotherapy
Have an infection of the pelvis
Have another medical condition that cannot be controlled with medication
Are taking St John’s Wort
Are pregnant or breastfeeding

Trial design

This is a national study. It will recruit about 80 people around the UK. Everybody taking part will have cetuximab, irinotecan, capecitabine and radiotherapy, followed by surgery.

You have 6 treatments of cetuximab. The first treatment is 1 week before you start radiotherapy. You have cetuximab each week until the end of radiotherapy. You have cetuximab through a drip in a vein (intravenous infusion). The first treatment takes 2 hours. Following treatments may only take 1 hour.

You have 4 treatments of irinotecan. The first treatment is in the second week, which is the same week you start radiotherapy. You have irinotecan each week for 3 more weeks. You have irinotecan through a drip in a vein. This takes 1 hour.

Capecitabine is a tablet. You have several tablets of capecitabine to take twice a day. You take these tablets Monday to Friday only, for 5 weeks. You do not take the tablets on the weekends. You are given enough capecitabine each week to take home. You start taking the tablets when you start radiotherapy.

You have radiotherapy Monday to Friday for 5 weeks.

You will have surgery 8 weeks after you finish radiotherapy.

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 and when you have surgery. 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 rectal 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
MRI scan of the pelvis
Chest X-ray
Blood tests including CEA
Ultrasound scan or CT scan of the liver

You have chemoradiation as an outpatient. In week 1 you go to the hospital for 1 day. In weeks 2 to 6 you go to the hospital every day, Monday to Friday to have your radiotherapy. One day each week, in weeks 2 to 6, you will have chemotherapy as well as radiotherapy.

You will have your operation to remove your rectal cancer 8 weeks after radiotherapy.

Two weeks before your operation you will have