COPELIA

The COPELIA trial is testing whether two new tablet medications delay progression of endometrial cancer more than chemotherapy alone.

Background

Over the last 20 years, there has been a 50% increase in the number of women in the UK developing endometrial cancer (cancer arising from the lining of the womb). For women with advanced disease, chemotherapy treatment is often recommended, but its benefits may be limited. New treatments are needed and so the COPELIA trial is testing whether two new tablet medications delay progression of endometrial cancer more than chemotherapy alone.

Recruitment

The COPELIA trial will recruit 129 adult women, with advanced endometrial cancer who require further treatment after initial chemotherapy.

Study design

Participants will be randomly allocated to one of three groups:

Group one will receive a routine chemotherapy treatment for patients with endometrial cancer known as paclitaxel. Paclitaxel works by stopping the growth of cancer cells. In this trial, paclitaxel is given via an hour-long infusion into a vein three times a month for six months.

Group two will receive paclitaxel treatment (as above) in addition to a new drug called cediranib. Cediranib is a tablet medication, taken once a day, that works by blocking new blood vessel formation. Cediranib has been tested in women with endometrial cancer, but not alongside chemotherapy treatment.

Group three will receive two new tablet medications, cediranib and olaparib. Cediranib is taken once a day and olaparib twice daily. Olaparib works by preventing cancer cells repairing DNA effectively. The use of olaparib and cediranib together has been shown to be effective in a type of ovarian cancer, but has not been tested as a treatment for endometrial cancer.

Patients will be recruited from cancer treatment centres.

Treatments will be for six months unless disease progresses. Patients may continue with cediranib and olaparib if they remain stable.