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

NCT03570437 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

  • Carcinosarcoma
  • Endometrial Neoplasms

Interventions

DRUG

Paclitaxel

80 mg/m2 on three days in a 28 day cycle (with 6 cycles)

DRUG

Cediranib

20 mg per day

DRUG

Olaparib

Olaparib tablets, 300 mg twice-daily

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Cardiff University

    collaborator OTHER

  • University of Manchester

    lead OTHER

Principal Investigators

  • Gordon Jayson · The Christie NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2023-01-31
Completion
2023-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03570437 on ClinicalTrials.gov