A trial of docetaxel with or without selumetinib for advanced melanoma (DOC-MEK)
Cancer type:
Status:
Phase:
This trial looked at docetaxel with or without selumetinib (AZD6244) for people whose melanoma cells didn’t have a change (
) in a gene called BRAF. This trial was for people whose melanoma had spread to the surrounding or to another part of the body. This is called advanced melanoma.
Doctors sometimes use chemotherapy drugs such as docetaxel (Taxotere) to treat advanced melanoma. But it doesn’t always work very well. Doctors hoped that using a new treatment called selumetinib with docetaxel may have worked better than docetaxel alone.
Selumetinib is a type of drug called a MEK inhibitor and it works by blocking growth signals. MEK is a protein that sends signals to cells telling them to divide and grow. Researchers hoped that selumetinib would reduce the amount of MEK and slow down or stop the growth of cancer.
The aims of this trial were to find out
- If docetaxel and selumetinib was better than docetaxel alone for advanced melanoma with no BRAF gene change
- More about the side effects
Summary of results
The researchers found that docetaxel with selumetinib was no better than docetaxel only for people with melanoma without a change in the BRAF gene.
This was a phase 2 trial. It recruited 83 people.
It was a randomised trial. The people taking part were put into treatment groups by a computer. Neither they nor their doctor were able to choose which group they were in and neither knew which group they were in. This is called a double blind trial.
- 41 people had docetaxel and selumetinib
- 42 people had docetaxel and a dummy drug (placebo)
After an average follow up of just over 13½ months, the researchers looked at the average length of time people were still alive and free of cancer. They found that for both groups it was around 4 months.
The average overall time that people lived was less than 12 months in both groups with no significant difference between them.
The side effects were similar between the 2 groups, although more people who had docetaxel and selumetinib had
- A drop in white blood cells causing an increased risk of infection
- Diarrhoea
- A rash
The trial team concluded that adding selumetinib to docetaxel didn’t help people with advanced melanoma without a BRAF gene change.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists () and published in a medical journal. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Prof Mark Middleton
Supported by
AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
NIHR Oxford Biomedical Research Centre
University of Oxford
Other information
This is Cancer Research UK trial number CRUKE/10/026.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
