Does Cediranib With Paclitaxel, or Cediranib and Olaparib, Treat Advanced Endometrial Cancer Better Than Paclitaxel?

• Status: Unknown status
• Trial end date: 2021-09-30

Summary

The COPELIA trial is evaluating two new tablet medications in endometrial cancer for the first time. It will include 129 women aged 16 years or older with advanced endometrial cancer whose cancer has worsened after their initial chemotherapy treatment. Participants will be allocated at random to one of three groups:

1. The first group (Arm 1) will receive a standard (routine) treatment for patients with endometrial cancer known as paclitaxel. This is a chemotherapy drug that is routinely used to treat patients with different cancers including ovarian, breast, lung and endometrial cancer. Paclitaxel works by stopping the growth of cancer cells.

2. The second group (Arm 2) will receive the standard paclitaxel treatment once a week in addition to a new drug called cediranib. Cediranib is a tablet medication and works by blocking new blood vessel formation. Cediranib has been tested in women with endometrial cancer before but not alongside chemotherapy treatment.

3. The third group (Arm 3) will receive two new tablet medications, cediranib and olaparib. Olaparib works by preventing cancer cells repairing DNA effectively. The use of olaparib and cediranib together has been shown to be effective in a common type of ovarian cancer but has not been evaluated as a treatment for endometrial cancer before.

The main objectives of the COPELIA trial are to work out:

1. Whether the two new treatments, cediranib-paclitaxel (Arm 2) and cediranib-olaparib (Arm 3) are more effective at controlling endometrial cancer than standard paclitaxel chemotherapy (Arm 1)

2. Whether the two new treatments cause more or fewer side-effects than standard chemotherapy

3. How each of these treatments impact on the daily life of women receiving the treatment by asking trial participants to regularly complete quality of life questionnaires

4. Whether we can learn how these treatments work in women with endometrial cancer by taking some additional blood tests for research. In women allocated to Arm 3 (and only at participating hospitals), we will ask permission to take a small biopsy from an area of cancer before they start treatment to see if we can predict which women may benefit from olaparib.

• Phase: Phase 2

Details

• Lead Sponsor: University of Manchester
• Collaborators: AstraZeneca; Cardiff University
• Treatments: Albumin-Bound Paclitaxel; Cediranib; Olaparib; Paclitaxel