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A trial for small cell lung cancer, looking at chemotherapy with or without pravastatin (LungStar)

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

This trial is looking at chemotherapy, with or without a drug called pravastatin, to treat people with small cell lung cancer (SCLC). Pravastatin belongs to a group of drugs called statins, one of the treatments used to lower cholesterol. This trial is supported by Cancer Research UK.

People with SCLC usually have chemotherapy to treat their cancer. This may work quite well at first, causing the cancer to shrink, or even disappear in some people. But sadly, the cancer comes back in most people.

We now know that lung cancer cells are driven to divide and grow by many different growth factors. These growth factors work by binding to specific receptors on the cell surface and telling the cancer to continue to grow. Doctors think that there is a molecule inside cancer cells which control the work of many different growth factors and receptors. It is thought that statins can block the activity of this molecule.

In laboratory research, statins have been shown to increase the effects of chemotherapy on lung cancer cells grown in the test tube. So doctors want to find out if this can also happen in humans with lung cancer.

To test this, the LungStar trial will compare chemotherapy and pravastatin together, with chemotherapy alone. The researchers aim to find out if adding pravastatin to the standard treatment can further prolong life and relieve symptoms.

Recruitment

Start 19/01/2007
End 31/12/2011

Phase

Phase 3

Who can enter

You can enter this trial if you

You cannot enter this trial if you

  • Have already had chemotherapy for your SCLC
  • Have already had radiotherapy to treat your SCLC (However, you may be able to take part if you have only had radiotherapy to treat cancer that has spread elsewhere in the body)
  • Have SCLC that has spread to your brain and is causing you symptoms that need immediate treatment with radiotherapy
  • Have any medical condition or illness that means you cannot have the treatment in this trial
  • Have had treatment with any statin drugs in the last 12 months
  • Are having treatment with cyclosporin
  • Are pregnant or breastfeeding
  • Have had any other type of cancer, unless there has been no sign of it for at least 3 years (apart from non melanoma skin cancer or carcinoma in situ of the cervix which have been treated)

Trial design

This national trial aims to recruit 842 people with SCLC. There are 2 treatment groups in this trial. The trial is randomised. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is common in clinical trials and is called a double blind controlled trial.

If you are in group 1, you will have chemotherapy and pravastatin. If you are in group 2, you will have chemotherapy and a dummy (placebo) tablet.

Neither you nor your doctor will know which treatment group you are in. So you will not know whether you are having pravastatin or the dummy tablet.

People in both groups will have standard chemotherapy treatment with either

Your doctor will decide which combination of drugs is best for you.

You will have etoposide with either cisplatin or carboplatin through a drip on day one. You will have etoposide again on the second and third day. You may have this through a drip, or as a tablet, depending on the hospital policy. You will then have no treatment for the next two weeks. This 3 week period is called a cycle of chemotherapy. You will have up to 6 cycles of chemotherapy.

You will also have either pravastatin or the placebo as a tablet every day for up to 2 years.

Hospital visits

Before you start your treatment, a doctor will examine you and you may have various tests. These tests include

  • Blood tests
  • Chest X-ray
  • CT scan of your chest and stomach

You may have your first cycle of chemotherapy as an in patient and stay in hospital overnight. You may be able to have the rest of your chemotherapy cycles as an outpatient. Your doctor will discuss this with you.

You will have blood tests and a chest X-ray before each cycle of chemotherapy to check that you are well enough to continue with treatment. You may have another CT scan after your 3rd and 6th cycle.

After you have finished chemotherapy, you will continue to see your doctor and have blood tests and chest X-rays. You may also have some scans. These appointments will be

  • Every 2 months for the 1st year
  • Every 3 months after that

As part of this trial you will have extra blood tests and may be asked to provide urine samples. You will have these tests at several points before during and after your treatment (about 4 to 5 times in total). This will mean that the research staff will take an extra 1 to 2 teaspoons of blood each time. Where possible, the blood samples will be taken at the same time you are due to have routine blood tests, so you will not have to have any extra needles.

The samples will be used to look at the genetic differences between people and how their bodies may respond differently to pravastatin. This information may help to improve treatment in the future.

Side effects

All treatments have possible side effects. The most common side effects of chemotherapy include

You can read about the particular side effects of carboplatin, cisplatin and etoposide by clicking on the drug names.

The side effects of pravastatin are usually quite mild. These include

  • Muscle weakness, tenderness or pain
  • Constipation
  • Itchy skin

Your doctor will be able to give you some medicine to relieve these side effects.

Pravastatin may cause abnormal liver blood test results. You may not have any symptoms. Your doctor will monitor your blood test results and if this becomes a problem, you may have to stop your pravastatin or placebo.

Location of trial

CLOSED

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.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor M.J. Seckl

This is Cancer Research UK trial number CRUK/06/009.

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
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Updated: 5 January 2012