Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Bevacizumab
- Conditions
- Ovarian Cancer
- Sponsor
- Yonsei University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Progression free survival (PFS)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who have histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer.
- •Patients who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen)
- •Patients who have underwent chemotherapy of either weekly paclitaxel + bevacizumab, topotecan + bevacizumab, pegylated liposomal doxorubicin + bevacizumab in 2nd line or 3rd line chemotherapy.
Exclusion Criteria
- •Patients with previous treatment with bevacizumab.
- •Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.
Arms & Interventions
Pegylated liposomal doxorubicin + bevacizumab
Intervention: Bevacizumab
Topotecan + bevacizumab
Intervention: Bevacizumab
Pegylated liposomal doxorubicin + bevacizumab
Intervention: Pegylated liposomal doxorubicin
Weekly paclitaxel + bevacizumab
Intervention: Weekly paclitaxel
Weekly paclitaxel + bevacizumab
Intervention: Bevacizumab
Topotecan + bevacizumab
Intervention: Topotecan
Outcomes
Primary Outcomes
Progression free survival (PFS)
Time Frame: 36 months
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria
Incidence of Treatment-Emergent Adverse Events
Time Frame: 36 months
Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.
Secondary Outcomes
- overall survival (OS)(36 months)
- Response rate(36 months)