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.
Lay summary of study results: The most common type of cancer of the womb is called endometrial cancer. This is a cancer that develops in the inside lining of the womb. Endometrial cancer causes bleeding, usually in women who have already completed their menopause. As a result, endometrial cancer is usually found at an early stage when it can be cured by surgery and sometimes chemotherapy and radiotherapy.
In a small proportion of patients, endometrial cancer can return and there are several different treatment options. In COPELIA, we compared the effectiveness and side effects of 3 different treatments in patients with recurrent endometrial cancer:
• Paclitaxel (also known as taxol), given for 3 out of 4 weeks.
• Weekly paclitaxel, given for 3 out of 4 weeks, with oral cediranib.
• Oral cediranib and oral olaparib.
Paclitaxel is a chemotherapy drug that has been used to treat endometrial cancer for many years. Cediranib is an oral drug that targets blood vessels inside cancers so that they are deprived of oxygen and nutrients; an anti-vascular drug. Olaparib is a drug that stops cells recovering from damage to DNA; a member of the PARP inhibitor family.
In COPELIA, 124 patients were randomly allocated to one of the three arms listed above. The main question was which treatment controlled the illness for at least 3 months. The results showed that the most effective treatment was the weekly paclitaxel and cediranib combination. It had a greater chance of shrinking the cancer than the other two treatments and kept the cancer under control in a larger number of patients than the other two arms. However, a greater number of patients, treated with paclitaxel and cediranib, had side effects from treatment. Significant side effects included diarrhoea, fatigue and raised blood pressure.
COPELIA has identified that weekly paclitaxel and cediranib is an effective treatment option in recurrent endometrial cancer. A larger randomised trial is needed to establish this combination as a standard of care.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