A trial looking at docetaxel and RAD001 for head and neck cancer that has spread or has come back after treatment (DORA)

This trial was trying to find out if having a drug called RAD001 (also called everolimus and Afinitor) at the same time as chemotherapy helped people with head and neck cancer that had spread or had come back after treatment. The trial was for people who had head and neck cancer that had started in the flat, skin like cells lining the cavities of the head and neck. These cells are called squamous cells. You may hear your doctor call this type of cancer squamous cell carcinoma . This trial was supported by Cancer Research UK.

Doctors often use surgery to treat head and neck cancers. But if head and neck cancer cannot be cured with surgery or comes back after treatment, you may have chemotherapy. Docetaxel is a chemotherapy drug that doctors often use.

RAD001 (also known as Everolimus) is a drug that was first developed for people who have had a heart or kidney transplant. It helps to damp down the immune system to stop the body rejecting the new organ. But we knew from research that RAD001 may also help to stop cancer cells growing.

In this trial, researchers wanted to find out if RAD001 helped people having chemotherapy for head and neck cancer that had spread or come back. The aims of the trial were to

• Find the best dose of RAD001 to have at the same time as docetaxel
• See if RAD001 and docetaxel together, worked better than docetaxel alone