
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.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at gemcitabine and carboplatin chemotherapy with a new drug called apatorsen for people with non small cell lung cancer (NSCLC) that has spread. It is for people with a type of NSCLC called squamous cell lung carcinoma. The trial is supported by CRUK.
Doctors usually treat non small cell lung cancer (NSCLC) that has spread outside the lung (advanced lung cancer) with chemotherapy. The standard chemotherapy drugs they use are called gemcitabine and carboplatin. They help, but doctors are always looking for ways to improve treatment. In this trial they are looking at a drug called apatorsen.
Apatorsen (OGX-427) is a new drug that targets a protein in the body called Hsp27. The Hsp27 protein can help cancer cells to protect themselves from cancer treatment. Hsp27 is only found in some types of lung cancer. The doctors in this trial think that by blocking Hsp27, or removing it from cancer cells, might help gemcitabine and carboplatin chemotherapy to work better.
The aims of this trial are to find out
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply.
This is a phase 2 trial. The researchers need 140 people to join the trial. It is a randomised trial.The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in
To begin with, the people in group 2 have apatorsen on 3 separate occasions over a 9 day period. This is called a loading dose and ensures that you have enough apatorsen in your body when you start the treatment cycles.
You have gemcitabine, carboplatin and apatorsen as injections into a vein. Everyone will have carboplatin once every 3 weeks and gemcitabine twice every 3 weeks. The people in group 2 also have apatorsen once a week. The treatment takes about 2 hours each time.
Each 3 week period is called a cycle of treatment. If the trial treatment is helping you and not causing bad side effects, you may have up to 6 cycles of treatment.
The researchers in this trial may ask for extra blood samples and samples of your cancer (a ). These samples will be stored safely and used only for research. They may help researchers learn more about lung cancer and how to treat it.
The trial team will ask you to fill out a questionnaire before you start treatment and at regular times during the trial. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
You will see the doctor and have some tests before you start treatment. The tests include
During treatment, you go to hospital once a week. You have regular blood tests. You have a CT scan every 6 weeks until your cancer starts to get worse.
After you finish treatment you see the trial team again. They will repeat some of the tests you had before you started the trial. The people will group 2 will have blood tests every 3 weeks. Everybody will continue to see the trial doctor every 2 months for up to 2 years.
Apatorsen is a new drug and there may be side effects we don’t know about yet. The most common side effects so far include
We have more information about gemcitabine and carboplatin.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Schmid
Barts Cancer Institute
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Oncogenex Pharmaceuticals Inc
Queen Mary University of London
This is Cancer Research UK number CRUKE/13/014
Freephone 0808 800 4040
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.