A trial looking at gefitinib for people with advanced cancer of the food pipe (oesophagus) - COG Trial
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Doctors often use chemotherapy to treat oesophageal cancer that has come back after treatment (recurrence) or has spread to another part of the body. But at some point the cancer will start to grow again. It is not clear at the moment what the best treatment is when this happens.
Gefitinib is a type of drug called a tyrosine kinase inhibitor (TKI). It works by blocking receptors on the surface of cells called 'epidermal growth factor receptors' (EGFR). Doctors hope that by blocking these receptors, they will be able to stop or slow down the growth of cancer cells. Gefitinb is also being looked at in other types of cancer.
Doctors hope that gefitinib will help people to live longer with oesophageal cancer that has come back. But they do not know this for certain. As all treatments have side effects, it is important that people do not have treatments that don’t work.
Half of the people in this trial will have gefitinib. The other half will have a dummy drug (placebo).
The aims of this trial are to
- Find out if gefitinib helps treat oesophageal cancer that is growing again after chemotherapy
- Learn more about the side effects of gefitinib and how they affect people’s quality of life
Who can enter
You can enter this trial if
- You have oesophageal cancer that has started to grow again after chemotherapy (the original cancer may have been where the oesophagus meets the stomach or just above - cancer of the oesophago-gastric junction)
- Your cancer can be measured on a CT scan
- You are well enough to take part (performance status 0,1 or 2)
- You are able to take tablets (either whole or dissolved in liquid)
- You have satisfactory blood test results
- You are willing to use reliable contraception if there is a chance that you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have already had more than 2 courses of chemotherapy and 1 course of chemotherapy and radiotherapy combined (chemoradiation)
- Have had chemotherapy in the last 6 weeks
- Have had radiotherapy to treat your cancer in the last 4 weeks
- Have cancer that has spread to the brain (if you have had radiotherapy to the brain and your condition is stable, you may be able to take part)
- Have or have had another type of cancer that could affect your taking part in this trial
- Have a condition called interstitial lung disease - you can check this with your doctor (If you have long term or stable disease you may still be able to take part)
- Have any other medical condition that would make it difficult for you to take part
- Are allergic to gefitinib or any of the other ingredients in the product
- Are taking any other drugs to treat your cancer, or hormone treatments (not including contraceptive pills) or as part of another clinical trial
- Are pregnant
This trial will recruit 450 people in total. It is a randomised trial. You will be put into one of two treatment groups by a computer. Neither you nor your doctor will be able to choose which group you are in, or be told which group you are in. This is called a double blind trial.
One group will take gefitinib tablets, and the other will take dummy tablets (placebo tablets). You take 2 tablets of gefitinib or placebo each day for 3 months. After this, if your doctors feel that the treatment is helping and you don’t have any serious side effects, you may be able to continue with it.
You will fill out 2 questionnaires
- Before you start treatment
- Every 4 weeks for the next 3 months
The questionnaires will ask about how you have been feeling, any changes to your daily activities and any pain you may have. These are called quality of life questionnaires.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood tests
- CT scan
You will go to the hospital every 4 weeks for the first 4 months, and then every 8 weeks for as long as you are taking part in this study. During these visits you will have blood tests and a CT scan.
All treatments have side effects. As gefitinib is a relatively new drug there may be some side effects that doctors don’t know about yet. In trials so far, the most common side effects are
- Feeling or being sick
- Skin rash which can look like acne and may be red and itchy
There is more information about the side effects of gefitinib on CancerHelp UK.
Location of trialCLOSED
For more information
Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.
Cancer Research UK
407 St John Street
This is Cancer Research UK trial number CRUK/07/017.
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