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 of chemotherapy and hydroxychloroquine for small cell lung cancer (STUDY 15)
This trial is looking at adding hydroxychloroquine to chemotherapy for people with small cell lung cancer that has spread. Lung cancer that has spread is called advanced lung cancer.
More about this trial
- if adding hydroxychloroquine to chemotherapy improves treatment for SCLC
- what the side effects are
- how hydroxychloroquine with chemotherapy affects
quality of life
Who can enter
- have small cell lung cancer that has spread (stage 4)
- have at least 1 area of cancer that doctors can measure on a scan
- are up and about for at least half the day, can look after yourself (ECOG performance status 0, 1 or 2)
- have satisfactory blood test results
- are able to have chemotherapy and to swallow tablets
- are willing to use reliable contraception during treatment and for 6 months after if there is any chance you or your partner could become pregnant
- are at least 18 years old
non small cell lung cancer (NSCLC) as well as small cell lung cancer (SCLC)
- have had already had treatment for small cell lung cancer apart from radiotherapy to the bones to relieve pain (palliative radiotherapy)
- have symptoms of the cancer spreading to the brain
- have had another cancer apart from
non melanoma skin cancer, early cervical canceror any other cancer if there hasn’t been any sign of it for the past 3 years
- have problems with your eyesight caused by age (macular degeneration) or caused by diabetes (diabetic retinopathy)
- are sensitive to or have had an allergic reaction to any other drugs used in the trial
- have side effects to chloroquine or similar drugs that doctors or nurses have noted
- have had chloroquine or similar drugs within the past year
- have HIV, hepatitis B, hepatitis C or any other blood virus
- have a heart trace (
ECG) that shows a slow heart rhythm (severe QT prolongation)
- are taking medication that affects the CYP enzymes for example, phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine
- take a medication called digoxin to regulate your heart rhythm and can’t have it monitored regularly while on the trial
- have any other medical or mental health condition that could affect you taking part
- are pregnant or breastfeeding
- 56 people have carboplatin and etoposide
- 56 people have carboplatin, gemcitabine and hydroxychloroquine
You have treatment in cycles. Each 3 week period is a cycle of treatment. You have between 4 and 6 cycles of chemotherapy.
- a drip on the first day of treatment and then as a tablet for next 2 days
- a drip for the 3 days
Carboplatin, gemcitabine and hydroxychloroquine
You have carboplatin as a drip. You have it once at the beginning of each cycle.
You have gemcitabine as a drip. You have it once a week for 2 weeks.
You then have 1 week of not having chemotherapy.
Hydroxychloroquine is a tablet. You have it twice a day, You start taking it on the 1st day of treatment. You can continue having hydroxychloroquine for 2½ years as long as it is helping you and the side effects aren’t too bad.
To help prevent an infection you might have
The trial team will ask for a small piece of tissue from the
They want to use these samples to find out more about small cell lung cancer.
You don’t have to agree to these if you don’t want to. You can still take part in the main trial.
Quality of life
Before you start treatment, at regular times during and after treatment you fill in a questionnaire. The questions ask about your general health and any side effects you might have. This is a
- a physical examination
- blood tests
- CT scan
- heart trace (
- eye test
- month for a year
- and then every 2 months for 2 years
- changes to your eyesight
- low amounts of sugar in your blood
- tummy (abdominal) pain
- itchy skin
- mood changes
- a build up of substances in the body causing you to be sick, constipated, confused, have chest pain, high temperature, high blood pressure and fast heartbeat. Contact your advice line or doctor if you have any of these symptoms
- changes to how you think and feel
- muscle weakness, cramping, stiffness, shaking, spasms
- changes to sensations such as tingling
How to join a clinical trial
Professor Siow Ming Lee
London Lung Cancer Group
University College London (UCL)