Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A trial to see if a body protein called ERCC1 affects how people with advanced non small cell lung cancer respond to different types of chemotherapy
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is trying to find out if chemotherapy without
Doctors may use surgery or radiotherapy to treat NSCLC. But if the cancer is advanced when it is diagnosed, this is not possible and you will probably have chemotherapy. Chemotherapy for NSCLC usually includes a platinum drug such as cisplatin. But this type of chemotherapy helps some people more than others.
Platinum drugs damage the genetic material inside cells (the DNA). ERCC1 is a protein that helps to repair any damage to DNA. Cancer cells may use ERCC1 to repair the damage caused by platinum drugs, which then allows the cancer to carry on growing. So it is possible that people with high levels of ERCC1 would do better having a different type of chemotherapy.
In this trial, some people will have chemotherapy that includes a platinum drug, some will have another type of chemotherapy. The researchers will look at everybody’s levels of ERCC1. They will then compare all the results from the 2 groups at the end of the trial.
The aims of the trial are to see
- If chemotherapy without a platinum drug is better for people with advanced non small cell lung cancer and high levels of ERCC1
- If chemotherapy including a platinum drug works as well, or better, for people who have low levels of ERCC1
Who can enter
You can enter this trial if
- You have been diagnosed with non small cell lung cancer that is stage 3B or stage 4
- There is a sample of cancer cells or tissue available from when you had a biopsy that can be tested for levels of ERCC1
- You are well enough to take part in the trial (performance status 0 or 1)
- You have satisfactory blood test results
- You are willing to use reliable contraception during the trial and for at least 6 months afterwards if there is any chance you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Have a type of non small cell lung cancer called squamous cell cancer
- Have cancer that has spread to your brain unless this has been successfully treated and has not got any worse in the last month
- Have had radiotherapy unless it was radiotherapy for symptoms
- Have had another cancer apart from non melanoma skin cancer or carcinoma in situ of the cervix, or any other type of cancer if you haven’t had any sign of the disease for at least 3 years
- Take aspirin or other non steroidal anti inflammatory drugs (NSAIDs) and there is a reason you cannot stop taking them (you should not stop taking medication without talking to your doctor)
- Have a build up of fluid in the lungs (a pleural effusion) or fluid in the abdomen (
ascites) that cannot be controlled
- Have another medical condition that the trial doctors think could affect you taking part
- Have had a yellow fever vaccination in the last month
- Are pregnant or breastfeeding
The trial will recruit about 1,300 people. If you agree to take part, the trial doctor will get a small sample of the cancer cells or tissue removed when you had a biopsy, and send it to a central laboratory. The sample will be tested to see how much ERCC1 it contains. If the laboratory is not able to measure this, you will not be able to continue in the trial.
Once the doctor knows that the level of ERCC1 has been measured, you will be put into a treatment group at random. Neither you nor your doctor can decide which group you are in. This is called randomisation.
The 2 possible treatments are
You also take folic acid tablets each day and have vitamin B12 injections every 9 weeks during treatment. Both of these help to reduce some of the side effects of pemetrexed.
You have the chemotherapy drugs through a drip into a vein once every 3 weeks. This will take a few hours each time. Each 3 week period is called a cycle of treatment. You have up to 6 cycles of treatment.
You will be asked to fill out a questionnaire when you join the trial, each time you have chemotherapy, at the end of treatment and then 6 months, a year, 18 months and 2 years after starting treatment. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
The doctors will ask to take an extra blood sample and to keep a small sample of the tissue from your
You see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination
- Chest X-ray
- CT scan
- Blood tests
You may need to stay in hospital overnight the first time you have chemotherapy. But after that, you can probably have chemotherapy as an outpatient. You have blood tests before each chemotherapy treatment. You have a CT scan after every 2 cycles of treatment. And you have a chest X-ray after every other cycle.
After you finish treatment, you see the trial doctors every month for a year and every 2 months after that. You will have a chest X-ray each time.
The side effects of chemotherapy include
- Tiredness (fatigue)
- Feeling or being sick
- Sore mouth
- Taste changes and loss of appetite
- Allergic reactions
- Change to your skin and nails
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Constipation or diarrhoea
- Numbness or tingling in your hands or feet (peripheral neuropathy)
- Change to your kidneys, heart or liver
- Changes in your hearing
- Hair loss
- Aching joints or muscles
- Headaches or abdominal pain
- Changes in your blood pressure
- Flu like symptoms
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.
Prof Siow Ming Lee
Cancer Research UK
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
UCL Cancer Trials Centre
This is Cancer Research UK trial number CRUKE/08/021.