A trial of ASA404 and docetaxel for non small cell lung cancer that has continued to grow during chemotherapy or has come back after treatment

Who can enter

You can enter this trial if

• You have non small cell lung cancer (NSCLC) that is stage 3b or has spread elsewhere in the body (stage 4)
• Your cancer that has continued to grow during chemotherapy or has come back after treatment
• You have satisfactory blood test results
• You are well enough to take part in the trial (performance status 0, 1 or 2)
• You are at least 18 years old
• You are willing to use reliable contraception during the trial and for 6 months afterwards if you are a woman and 3 months afterwards if you are a man if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

• Have cancer spread to your brain, unless this has been successfully treated with radiotherapy or surgery
• Have had any other cancer in the last 5 years apart from non melanoma skin cancer or cervical cancer in situ
• Have had radiotherapy in the last 2 weeks or have not recovered from side effects of earlier treatment
• Finished chemotherapy less than 3 weeks ago (6 weeks if you had drugs called mitomycin, streptozocin, lomustine, carmustine or bevacizumab (Avastin)
• Have already had docetaxel chemotherapy
• Have had minor surgery in the last 2 weeks, major surgery with a general anaesthetic in the last 4 weeks, or have not recovered from an earlier operation
• Have had any other experimental drug as part of another clinical trial in the last 4 weeks
• Have had any other drug that targets the cancer’s blood supply (your doctor can advise you about this)
• Have fluid on the lung (pleural effusion) that makes you very short of breath
• Have coughed up more than a teaspoon of blood at one time in the last 4 weeks
• Have high blood pressure that cannot be controlled with medication
• Have heart problems or take medication that could affect your heart (your doctor can advise you about this)
• Have any other serious medical condition that cannot be controlled with medication
• Have numbness or tingling in the arms or legs (peripheral neuropathy) unless it is very mild
• Are known to be sensitive to docetaxel or similar drugs
• Are known to be HIV positive
• Are pregnant or breastfeeding

Trial design

This international study will recruit about 900 people in different countries. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And you will not know which group you are in either. This is called a double blind trial.

People in group 1 have docetaxel and ASA404 through a drip into a vein every 3 weeks. This takes about an hour and a half all together. Each 3 week period is called a cycle of treatment. You have up to 6 cycles of treatment, lasting about 4 months in total.

People in group 2 have treatment in the same way, but they have a dummy drug (placebo) instead of ASA404.

If the treatment is helping you, the trial doctors may suggest you carry on having the ASA404 (or dummy drug) after you finish 6 cycles of docetaxel.

Everybody taking part will be asked to fill out a questionnaire at the beginning of the trial, every 6 weeks during treatment, and at the end of treatment. The questionnaire will ask about side effects and how you have been feeling. This is called a quality of life study. If you carry on having ASA404 or the dummy drug after the first 6 cycles of chemotherapy, you will fill out a questionnaire every 6 weeks for as long as you continue the treatment.

As part of this trial, the researchers are trying to find biomarkers. These are substances in the body that doctors can measure to help them see how a disease is developing or a treatment is working. To look for biomarkers, the trial team will take extra blood samples from you before, during and after treatment. And they will get a sample of the tissue that was removed when you had surgery or a biopsy to diagnose your lung cancer. These samples will be stored safely and may be used in the future, but only for research purposes.

The researchers also want to learn more about what happens to ASA404 in the body. This is called pharmacokinetics. So you may have some extra blood tests on day 1 of each treatment cycle.

Hospital visits

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

• Physical examination
• Heart trace (ECG)
• Blood tests
• Urine test
• CT scan or MRI scan
• Eye tests

You go to the hospital twice in each 3 week cycle of treatment. On the day you have chemotherapy, you will see the doctors. And you have blood tests, a urine test and 2 ECGs. Each of these visits can last up to 3 and a half hours. You have more blood tests half way though each cycle of treatment. And you have a CT or MRI scan after every 2 cycles of treatment.

After you finish treatment, you will see the trial doctors and have another scan, an ECG, blood tests, urine tests and an eye test. A member of the trial team will then contact you every 6 weeks to see how you are. You may see them at hospital appointments, or they may talk to you on the phone. You have a scan every 6 weeks until either your cancer starts to grow again, or you start another type of treatment.

Side effects

As ASA404 is a new drug, there may be some side effects we don’t know about yet. In trials so far, the side effects have included

• Sickness
• Tiredness (fatigue)
• Diarrhoea
• High or low blood pressure
• Pain where the drug is injected or where the cancer is
• Headaches
• Hot flushes and dizziness
• Aching muscles

ASA404 can cause changes to your vision. If you notice any changes in your sight, such as blurred vision, you must tell your doctor straight away. It can also cause changes to how your heart beats. So you will have a number of heart traces (ECGs) during the trial to check this.

In an earlier study when ASA040 was given at the same time as docetaxel, the side effects included

• Hair loss
• Sickness
• Fatigue, weakness or dizziness
• Constipation or diarrhoea
• Headache or chest pain
• Joint or muscle pain, or pain and redness in the arm where you have the treatment
• Pain, numbness or tingling in the arms or legs (peripheral neuropathy)
• A drop in the number of blood cells causing an increased risk of infection, tiredness and breathlessness
• A loss of appetite or taste changes
• Shaking
• Difficulty sleeping
• Breathing problems and cough

There is more information about the side effects of docetaxel on CancerHelp UK.