NCT03570437: COPELIA

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

Status unknown Phase 2 Last updated 2 March 2022

What this trial tests

Phase 2 trial testing Paclitaxel in Carcinosarcoma in 124 participants. Status unknown.

Timeline

17 May 2018

Primary endpoint
31 January 2023

30 June 2023

Quick facts

Lead sponsor	University of Manchester
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	17 May 2018
Primary completion	31 January 2023
Estimated completion	30 June 2023
Sites	15 locations across United Kingdom

Drugs / interventions tested

• Paclitaxel — full drug profile →
• Cediranib — full drug profile →
• Olaparib (olaparib) — full drug profile →

Conditions studied

• Carcinosarcoma — all drugs for Carcinosarcoma →
• Endometrial Neoplasms — all drugs for Endometrial Neoplasms →

Sponsor

University of Manchester

Who can join

16 and older, female only, with Carcinosarcoma or Endometrial Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PARP inhibitors: enhancing efficacy through rational combinations.
   Bhamidipati D, Haro-Silerio JI, Yap TA, Ngoi N. · · 2023 · cited 118× · PMID 37430137 · DOI 10.1038/s41416-023-02326-7
2. Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
   Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
3. Immunotherapy in endometrial cancer: new scenarios on the horizon.
   Di Tucci C, Capone C, Galati G, Iacobelli V, et al · · 2019 · cited 83× · PMID 30887763 · DOI 10.3802/jgo.2019.30.e46
4. PARP Inhibitors in Endometrial Cancer: Current Status and Perspectives.
   Musacchio L, Caruso G, Pisano C, Cecere SC, et al · · 2020 · cited 33× · PMID 32801862 · DOI 10.2147/cmar.s221001
5. Small-Molecule Inhibitors (SMIs) as an Effective Therapeutic Strategy for Endometrial Cancer.
   Megino-Luque C, Moiola CP, Molins-Escuder C, López-Gil C, et al · · 2020 · cited 17× · PMID 32987790 · DOI 10.3390/cancers12102751
6. Fibroblast growth factor receptor signaling as therapeutic targets in female reproductive system cancers.
   Zhu DL, Tuo XM, Rong Y, Zhang K, et al · · 2020 · cited 15× · PMID 33193890 · DOI 10.7150/jca.44727
7. Heterogeneous Circulating Tumor Cells in Sarcoma: Implication for Clinical Practice.
   Agnoletto C, Caruso C, Garofalo C. · · 2021 · cited 12× · PMID 34063272 · DOI 10.3390/cancers13092189
8. PARP inhibitors and immunotherapy in ovarian and endometrial cancers.
   Miller RE, Lewis AJ, Powell ME. · · 2021 · cited 9× · PMID 33882241 · DOI 10.1259/bjr.20210002