A trial of docetaxel with or without AZD6244 for advanced melanoma (DOC-MEK)

Please note this trial is no longer recruiting patients.

This trial is looking at docetaxel with or without AZD6244 for people whose melanoma cells don’t have a change in a gene called BRAF.

Doctors sometimes use chemotherapy drugs such as docetaxel (Taxotere) to treat advanced melanoma. But it doesn’t always work very well. Doctors hope that using a new treatment called AZD6244 with docetaxel may work better than docetaxel alone.

AZD6244 is a type of drug called a MEK inhibitor and it works by blocking growth signals. MEK stands for mitogen activated protein kinase. It is a protein that sends signals to cells telling them to divide and grow. Researchers hope that AZD6244 will reduce the amount of MEK and slow down or stop the growth of cancer.

In this trial they are looking at how well AZD6244 works for people who do not have a change (mutation) in a gene called BRAF in their melanoma cells.

The aims of this trial are to find out

If docetaxel and AZD6244 is better for advanced melanoma than docetaxel alone
More about the side effects

Recruitment

Start 26/10/2010

End 21/05/2012

Phase

Phase 2

Who can enter

You can enter this trial if you

Have stage 3 or 4 melanoma skin cancer
Do not have a mutation in the BRAF gene in your melanoma cells
Have an area of melanoma that can be measured on a scan
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are at least 16 years old
Are prepared to use reliable contraception while you are taking part in the trial

You cannot enter this trial if you

Have melanoma of the eye or of the tissue that lines the mouth, nose or food pipe for example (mucosa)
Have melanoma that has spread to the brain, unless it has been successfully treated and stable (without treatment) for at least 3 months
Have had treatment for your melanoma in the last 4 weeks
Have had chemotherapy for advanced melanoma
Have had a treatment that targets EGFR, RAS, RAF or MEK gene mutations before (you can check this with your doctor)
Are having treatment that reduces or inhibits an enzyme called CYP3A4 (you can check this with your doctor)
Are still having side effects from treatment you have had
Have had any other cancer in the last 5 years
Have heart problems such as uncontrolled high blood pressure or have had a heart attack in the last 6 months
Are not able to swallow tablets or absorb medicine from your stomach
Have any other serious medical condition
Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit about 80 people into 2 groups. The people taking part will be put into treatment groups by a computer. Neither you nor your doctor will be able decide which group you are in. Nor will you know which group you are in. This is called a ‘double blind’ trial.

The people in group 1 will have docetaxel through a drip into a vein once every 3 weeks. Each 3 week period is one cycle of treatment. You will have up to 6 cycles. And you will take dummy (placebo) tablets twice a day, every day, until there are signs that your cancer has started to grow again.

The people in group 2 will have docetaxel into a vein once every 3 weeks. You will have up to 6 cycles. And you will take AZD6244 tablets twice a day, every day, until there are signs that your cancer has continued to grow again.

Hospital visits

You will see the doctors and have some tests before you take part in this trial. They include

Physical examination
Blood tests
CT scan or MRI scan (if you haven’t had one in the last 4 weeks)

You will have a heart trace (ECG) before, and 2 hours after, your first dose of treatment.

You will have blood tests, urine tests and a physical examination before each cycle of treatment. And you will have a CT scan after 4 and 6 cycles of treatment.

You will see the doctors every 3 months after you finish chemotherapy, until you stop taking AZD6244 (or the placebo). You will see the trial doctors a month after you stop treatment. After that you will continue to see your own cancer specialist.

Side effects

AZD6244 is a new treatment so there may be side effects we don’t know about yet. But the most common side effects we know about so far are

Rash
Diarrhoea
Fluid retention
Feeling or being sick
Shortness of breath
Tiredness
High blood pressure
Sore eyes or blurred vision

The most common side effects of docetaxel are

A drop in blood cells causing an increased risk of infection, bleeding or bruising problems, tiredness and shortness of breath
Feeling or being sick
Fluid retention
Sore mouth (mucositis)
Hair loss
Diarrhoea

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