Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer

Sponsor
Yonsei University
Study ID
NCT03367182
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Weekly paclitaxel — DRUG
    Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
  • Topotecan — DRUG
    Drug: topotecan 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
  • Pegylated liposomal doxorubicin — DRUG
    Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks
  • Bevacizumab — DRUG
    Drug: bevacizumab \[Avastin\] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Study Details

This study will evaluate the efficacy and safety profile, response rate, progression free survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with disease progression within 6 months of platinum treatment.

Key Dates

First listed
Dec 8, 2017
Start date
Sep 1, 2017
Status verified
Jan 2019
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
50 participants (actual)

Arms

  • Arm: Weekly paclitaxel + bevacizumab
  • Arm: Topotecan + bevacizumab
  • Arm: Pegylated liposomal doxorubicin + bevacizumab

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: 36 months ]

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