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

Sponsor
University of Manchester
Study ID
NCT03570437
Phase
PHASE2
Status
Unknown

Conditions

  • Carcinosarcoma
  • Endometrial Neoplasms

Eligibility Criteria

Sex
FEMALE
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    80 mg/m2 on three days in a 28 day cycle (with 6 cycles)
  • Cediranib — DRUG
    20 mg per day
  • Olaparib — DRUG
    Olaparib tablets, 300 mg twice-daily

Study Details

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.

Key Dates

Start date
May 17, 2018
Status verified
Feb 2022
Primary completion
Jan 31, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
124 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Paclitaxel
    Paclitaxel 80 mg/m2 administered on days 1, 8 and 15 of a 28-day cycle for up to 6 cycles.
  • Experimental: Arm 2: Cediranib and paclitaxel
    Cediranib 20 mg once daily for 28 days given with weekly paclitaxel 80 mg/m2 administered on days 1, 8 and 15 of a 28-day cycle for up to 6 cycles. Participants with stable disease or better will be able to continue cediranib once daily until disease progression.
  • Experimental: Arm 3: Cediranib and olaparib
    Cediranib 20 mg once daily with olaparib 300 mg twice daily, continuously on a 28 day cycle for up to 6 cycles. Participants with stable disease or better will be able to continue with olaparib and cediranib until disease progression.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 3 months ]

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