A trial looking at ZD4054 with chemotherapy to treat bowel cancer that has spread - FOLFERA

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 giving a new drug called ZD4054 with chemotherapy to treat people with bowel cancer that has spread to another part of the body. This trial is supported by Cancer Research UK.

Doctors usually treat advanced bowel cancer with chemotherapy. One combination of drugs they use is irinotecan, fluorouracil (5FU) and folinic acid Open a glossary item . This combination of chemotherapy is known as FOLFIRI.

Cancer cells need messages to tell them to grow, multiply and spread. ZD4054 blocks one of these messages. We know from research that combining ZD4054 with chemotherapy may help people with other types of cancer. The researchers hope that combining ZD4054 with FOLFIRI can help people with advanced bowel cancer.

The aims of this trial are to find out

How well the combination of ZD4054 and FOLFIRI works for people with bowel cancer that has spread
How safe it is

Who can enter

You can enter this trial if you

Have bowel cancer that has spread to another part of the body
Have had a chemotherapy drug called oxaliplatin in the last 6 months and your cancer had started to grow again
Have a tumour that can be measured on a scan
Have satisfactory blood test results
Are well enough to carry out all your normal activities, apart from heavy physical work (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

Your cancer has spread to the brain or spinal cord
Your cancer has spread to the bones
You have had chemotherapy, endocrine therapy, immunotherapy or radiotherapy in the last 4 weeks (you may join the trial if your radiotherapy was to control symptoms)
You have had more than 1 course of treatment with chemotherapy before (your doctor can advise)
You have had a chemotherapy drug called irinotecan before
You have had ZD4054 before
You have had radiotherapy that could cause a drop in the amount of blood cells your body can make (your doctor can advise about this)
You have had major surgery in the last 4 weeks
You have, or have had, another cancer
You have a serious heart problem
You have an infection
You have a problem with your digestion
You are known to be HIV, hepatitis B or hepatitis C positive
You have another medical condition that could affect you taking part in the trial

Trial design

This is a phase 2 trial. It will recruit about 20 people to start with. This is to see how safe using ZD4054 is, and what the side effects might be. If this looks all right, it will go on to recruit another 102, giving a total of 122 people in the trial.

This is a randomised trial. The people taking part are put in to 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in. Neither you nor your doctor will know which group you are in. This is called a ‘double blind’ trial.

Everyone taking part will have irinotecan, fluorouracil and folinic acid (FOLFIRI chemotherapy). Half the people will have ZD4054 and the other half will a have a dummy drug (placebo).

You have the irinotecan, fluorouracil and folinic acid in 2 week cycles of treatment. You have up to 12 cycles of treatment.

On day 1 of each cycle you have the folinic acid and irinotecan through a drip into a vein over 2 hours. You then have a slow injection of fluorouracil over about 5 minutes. Finally, you have an infusion of fluorouracil over 46 hours.

Most hospitals can give you a portable pump so that you can go home during the infusion. To use a pump, you need to have a central line or a PICC line. This will mean that you still have to visit hospital once a fortnight but shouldn’t need to stay in overnight.

ZD4054 and the dummy drug are tablets. You take one a day for at least 24 weeks. After completing your chemotherapy you may be able to continue taking these tablets. If you continue to have the tablets you will see the doctor every month to see how you are and to pick up tablets for the next month.

You have a diary to write down when you take your tablet each day and note any side effects you may have.

If you take part in this trial, the researchers will ask your permission for some extra blood samples and samples of tissue from when you had your biopsy. By studying these samples, the researchers will be able to better understand how ZD4054 and FOLFIRI work together in bowel cancer.

If you don’t want to give permission for these samples you do not have to. You can still take part in the trial.

You cannot take certain medication when you are taking ZD4054, or the placebo, because they can interfere with the way ZD4054 works in your body. Your doctor will advise about this.

Hospital visits

You will see the doctor and have some tests before starting treatment. These tests include

Physical examination
Heart trace (ECG )
Blood tests
Urine test
CT scan
Pregnancy test (if appropriate)

At the start of each cycle of treatment you see the doctor and have a physical examination and blood tests.

At week 8 and 16 you have a CT scan.

While taking ZD4054, or placebo, you see the doctor every month. You see the doctor 30 days after finishing ZD4054, or placebo, and then at 36, 48 and 60 weeks after you were put into your treatment group.

Side effects

The most common side effects of 5FU and irinotecan are

A drop in blood cells causing an increased risk of infection, bruising or bleeding problems
Tiredness (fatigue)
Feeling, or being, sick (nausea)
Diarrhoea
Hair loss
Loss of appetite
Sore mouth
Increased sweating
Increased saliva production
Watery eyes