A trial looking at Rad 001, cisplatin and etoposide for small cell lung cancer

Please note this trial is no longer recruiting patients.

This trial is looking at a new drug called Rad 001, in combination with cisplatin and etoposide chemotherapy for small cell lung cancer in people with extensive disease.

Doctors use chemotherapy to treat small cell lung cancer. The drugs they give most often are cisplatin and etoposide.

Rad 001 (Certican) is a drug that was first developed for people who have had a heart or kidney transplant. It helps to stop the body rejecting the new organ. But research has shown that Rad 001 may also help to stop cancer cells growing.

In this trial, the researchers are adding Rad 001 to chemotherapy, to see if it helps people with small cell lung cancer.

The aims of the trial are to

Find out how well the combination of Rad 001 and chemotherapy works for extensive stage small cell lung cancer
See how safe the treatment is
Learn more about the side effects

Recruitment

Start 01/04/2007

End 01/10/2008

Phase

Phase 1

Who can enter

You can enter this trial if you

Have extensive disease small cell lung cancer
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 if there is any chance you or your partner could become pregnant
Are at least 18 years old

You cannot enter this trial if you

Have already had chemotherapy for small cell lung cancer
Have cancer that has spread to your brain and is causing symptoms
Have had any other cancer in the last five years, apart from non melanoma skin cancer or carcinoma in situ of the cervix that have been successfully treated
Have not recovered from recent surgery, or may need to have surgery in the near future
Have had radiotherapy to a large part of your body, involving a quarter or more of your bone marrow in the last 4 weeks (your doctor can advise you on this)
Have had radiotherapy to a smaller part of your body to control symptoms in the last 2 weeks
Have recently taken part in another clinical trial or have not recovered from side effects of an experimental treatment you had in the past
Have had a heart attack in the last 6 months or have another heart condition that is a cause for concern
Have an infection that is not responding to treatment
Have a condition that makes it difficult for you to take or absorb tablets
Have any other serious medical condition including, but not limited to, diabetes that is not well controlled, liver or kidney disease
Are taking steroids or other drugs to suppress your immune system (please note, it is important that you do not stop taking steroids unless your doctor tells you to)
Have already had Rad 001 or a similar drug
Are known to be HIV positive
Are pregnant or breastfeeding

Trial design

This is an international phase 1 trial. It will recruit up to 60 people over 2 years. The people taking part are put into 1 of 2 treatment groups. Neither you, nor your doctor can decide which group you are in.

Everybody taking part in the trial will have cisplatin, etoposide and Rad 001 in 3 week (21 day) cycles of treatment. You have cisplatin on day 1 of each cycle and etoposide on days 1, 2 and 3. You have both drugs through a drip into a vein. It takes about an hour to have each one.

You have Rad 001 as tablets. How often you have the tablets will depend on which treatment group you are in.

Group 1 have Rad 001 tablets each day.

Group 2 have Rad 001 tablets once a week.

Both groups have the same dose of Rad 001 overall. You have up to 6 cycles of treatment, lasting up to 18 weeks. If your doctors think that Rad 001 is helping you, they may suggest you carry on taking the tablets after you finish chemotherapy. You can continue to take it for as long as it helps you.

On the 1st day of treatment, the doctors will take some blood samples to measure the amount of each chemotherapy drug that gets into your bloodstream. They will take more blood samples during the trial to learn more about all 3 drugs.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Physical examination
Blood tests
CT scan
Heart trace (ECG)
Lung tests
Urine tests

Women taking part in the trial who are able to become pregnant, will have a pregnancy test before they start treatment and another one at the end of the trial.

You will have your treatment in the hospital outpatient department. Most people will not need to stay in hospital overnight. On the 1st day of your treatment, the doctors will take blood samples at different times during the day. So, you will be at the hospital for about 12 hours. This will be the same on day 1 of the 2nd cycle of treatment. For the remaining 4 cycles, you will be at the hospital for about 8 hours on day 1.

You go to the hospital on day 2 and day 3 of each cycle to have blood tests and etoposide. Each of these visits will last about 4 hours.

On day 8 of the 1st cycle, you have 5 more blood tests, so you will be at the hospital most of the day. You also have blood tests on day 9 and day 15.

From the 2nd cycle onwards, you don’t need to have a blood test on day 9. But you will see the doctors and have blood tests each week (days 8 and 15). You have a CT scan after every 2 cycles of chemotherapy.

You will see the doctors at the end of the treatment and again 4 weeks later. If you carry on having Rad 001 after you finish chemotherapy, you will see the doctors once a month. And you will have a CT scan every 2 months.