“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial to see if there is a link between the enzyme thymidylate synthase and how people respond to treatment for non small cell lung cancer (The TS Study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is trying to find out if a substance produced in the body called thymidylate synthase affects how people respond to chemotherapy for non small cell lung cancer (NSCLC).
Thymidylate synthase (TS) is a substance that the body produces naturally. Cancer cells need TS to be able to copy their DNA before they divide into 2 new cells.
Researchers think that treatment for NSCLC may work better in people who have low levels of TS in their body. But they don’t know this for sure yet. So in this trial, they will measure the TS levels of everybody having treatment.
The aim of the trial is to see if there is a link between how much TS people produce and how well they respond to treatment with pemetrexed and cisplatin for non small cell lung cancer.
Who can enter
You can enter this trial if you
- Have been diagnosed with non small cell lung cancer (NSCLC) that is stage 3B or stage 4 and can be seen on a CT scan or a PET-CT scan
- Are well enough to take part in the trial (performance status 0 or 1)
- Have satisfactory blood test results
- Are willing to use reliable contraception during the trial and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have non small cell lung cancer that is mostly
squamous cell cancer(your doctor will advise you about this)
- Have cancer that has spread to your brain or spinal cord, unless this has been successfully treated
- Have already had treatment for NSCLC, apart from radiotherapy to relieve symptoms (palliative radiotherapy)
- Have had radiotherapy to more than a quarter of your
bone marrowor to all of your pelvis(you can check this with your doctor)
- Have had radiotherapy in the last month or have not recovered from side effects of earlier treatment
- Are currently having any other cancer treatment
- Have had any other cancer, apart from non melanoma skin cancer that has been successfully treated or another cancer that has been in
complete remissionfor at least 5 years
- Have a build up of fluid in the lungs (a pleural effusion) or abdomen (
ascites) that cannot be controlled
- Have any other serious illness that would make it unsafe for you to take part in the trial
- Have had any other experimental drug as part of a clinical trial in the last month
- Have had a yellow fever vaccination in the last month or plan to have one
- Take aspirin (apart from a low daily dose) or other non steroidal anti inflammatory drugs and are not able to stop taking them for a few days at a time
- Cannot have
steroids, folic acid tablets or vitamin B12 injections
- Are pregnant or breastfeeding
You have the drugs through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. You have 4 cycles of treatment, lasting about 3 months all together. To help control the side effects of pemetrexed, you take a steroid tablet called dexamethasone for 3 days in each cycle of treatment. You also have folic acid tablets every day, and vitamin B12 injections every few weeks.
If this treatment helps you, you may then continue to have pemetrexed on its own, through a drip every 3 weeks. You can continue having pemetrexed on its own until your doctor decides this treatment is no longer helping you, or until you choose to stop the treatment.
You will see the doctors and have some tests before you start treatment. The tests include
You go to hospital every 3 weeks to have treatment. You see the trial doctors and have blood tests at each visit. You have a scan at every other visit.
After you finish treatment you will see the doctors a month later. And you may have another scan. Then you will have follow up appointments with the trial team every 6 weeks.
The side effects of pemetrexed and cisplatin include
- A drop in the number of blood cells leading to an increased risk of infection, tiredness, bruising and bleeding problems
- Diarrhoea or constipation
- Hair loss
- Loss of appetite
- Sore mouth
- Skin rash
- Abdominal (tummy) pain
- Swelling of the limbs or face caused by a build up of fluid
- Weakness and tiredness (fatigue)
- Breathing problems or cough
- Headache, ringing in the ears or dizziness
- Tingling or numbness in the hands or feet (peripheral neuropathy)
- Kidney damage
Dexamethasone is a steroid. Side effects can include swelling from a build up of fluid, high blood pressure, increased appetite and weight gain.
The possible side effects of folic acid tablets include an allergic reaction and rarely, a mild stomach upset. You have vitamin B12 injections into a muscle. These can be a little painful and some people may have a reaction to the injections.
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.
Dr Mayukh Das
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)