COPELIA
Research type
Research Study
Full title
A 3-Arm Randomised Phase II Evaluation of Cediranib in Combination with Weekly Paclitaxel or Olaparib Versus Weekly Paclitaxel Chemotherapy as Second-Line Therapy for Advanced/Metastatic Endometrial Carcinoma or for disease relapse within 12 months of adjuvant carboplatin-paclitaxel chemotherapy.
IRAS ID
216069
Contact name
Gordon Jayson
Contact email
Sponsor organisation
The University of Manchester
Eudract number
2016-004617-28
ISRCTN Number
ISRCTN16320634
Clinicaltrials.gov Identifier
U1111-1197-9991, WHO UTN
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Does cediranib together with paclitaxel chemotherapy, or cediranib and olaparib, treat advanced endometrial cancer better than paclitaxel chemotherapy?
In the UK there has been a 50% increase over the last 20 years in the number of women developing endometrial cancer (cancer arising from the lining of the womb). There is a need for new treatments for recurrent/advanced endometrial cancer.
The COPELIA trial is testing whether two new treatment combinations, cediranib-paclitaxel and cediranib-olaparib are better at controlling endometrial cancer than usual chemotherapy. This trial will include 129 women (16 years+) with advanced endometrial cancer whose cancer has worsened after initial chemotherapy.
Participants will be randomly allocated to one of three groups:
The first group will receive a chemotherapy drug called paclitaxel which is routinely used to treat patients with endometrial cancer. Paclitaxel works by stopping the growth of cancer cells. Paclitaxel will be given via an hour-long infusion into a vein once a week.
The second group will receive the standard paclitaxel treatment once a week in addition to a new drug called cediranib. Cediranib is a tablet medication that is taken once a day and works by blocking new blood vessel formation. Cediranib has been tested in women with endometrial cancer before but not alongside chemotherapy treatment.
The third group 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 common type of ovarian cancer but has not been evaluated as a treatment for endometrial cancer before.
The treatment is expected to last 6 months, but cediranib and olaparib treatment may be continued until the cancer progresses. Participants will attend an NHS hospital for trial visits.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
17/SC/0536
Date of REC Opinion
30 Nov 2017
REC opinion
Further Information Favourable Opinion