A trial of chemotherapy and hydroxychloroquine for small cell lung cancer (STUDY 15)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Secondary cancers

Small cell lung cancer

Status:

Closed

Phase:

Phase 2

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

One of the treatments for small cell lung cancer (SCLC) Open a glossary item

is chemotherapy. The chemotherapy most often used is a carboplatin and etoposide. This is a standard treatment Open a glossary item

Recent research shows that a drug called hydroxychloroquine (HCQ) might help chemotherapy work better. It does this by making the cancer drugs more sensitive to chemotherapy.

We know from research that you can’t have etoposide with hydroxychloroquine. Gemcitabine is another chemotherapy drug similar to etoposide. In this trial people who have hydroxychloroquine will have gemcitabine instead of etoposide.

In this trial half the people have carboplatin and etoposide. And the other half have carboplatin, gemcitabine and hydroxychloroquine.

The aims of this trial are to find out:

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

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply.

You:

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

Who can’t take part

You cannot join this trial if any of these apply.

You:

have 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 cancer or 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

Trial design

This is a phase 2 trial. The team need 112 people to join.

It is a randomised trial. Neither you nor your doctor can choose which group you are in. Everyone is put into 1 of 2 groups.

56 people have carboplatin and etoposide
56 people have carboplatin, gemcitabine and hydroxychloroquine

16263_sclc.png

You have treatment in cycles. Each 3 week period is a cycle of treatment. You have between 4 and 6 cycles of chemotherapy.

Carboplatin and etoposide

You have carboplatin as a drip into a vein. You have it once at the beginning of each cycle.

You have etoposide for the first 3 days of each cycle of treatment. You have it either as:

a drip on the first day of treatment and then as a tablet for next 2 days

a drip for the 3 days

You then have 2 weeks of not having treatment.

16263_sclc_2.png

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.

16263_sclc_3.png

To help prevent an infection you might have antibiotics Open a glossary item

and G-CSF

. You have antibiotics as a tablet or capsule. You have G-CSF as an injection under the skin Open a glossary item

. Your doctor or nurse will tell when and how often you have these.

Samples
The trial team will ask for a small piece of tissue from the sample Open a glossary item taken when you were first diagnosed. They will also ask for extra blood samples when you agree to join the trial.

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 quality of life questionnaire Open a glossary item .

Hospital visits

You see the doctor to have some tests before you take part. These tests include:

a physical examination
blood tests
CT scan
heart trace (ECG )
eye test

During chemotherapy everyone sees the doctor at the start of each cycle (every 3 weeks). People taking hydroxychloroquine also see the doctor at the start of the 2nd week of the cycle.

After finishing chemotherapy, you see the doctor every:

month for a year
and then every 2 months for 2 years

Side effects

The trial team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.

The side effects of hydroxychloroquine include:

changes to your eyesight
low amounts of sugar in your blood
diarrhoea
tummy (abdominal) pain
itchy skin
mood changes
swelling
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

We have information about the side effects of:

Your doctor will talk to you about the possible side effects of all the drugs used in this trial before you agree to take part.

Recruitment start:

14/03/2017

Recruitment end:

26/03/2020

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.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Siow Ming Lee

Supported by

London Lung Cancer Group
University College London (UCL)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Email

Last review date

10 November 2020

CRUK internal database number:

16263