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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Weekly paclitaxel
* Drug: Topotecan
* Drug: Pegylated liposomal doxorubicin
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Weekly paclitaxel + bevacizumab<br> | Drug: Weekly paclitaxel<br>* Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle<br>Drug: Bevacizumab<br>* Drug: bevacizumab [Avastin] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks<br>|
| Topotecan + bevacizumab<br> | Drug: Topotecan<br>* 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<br>Drug: Bevacizumab<br>* Drug: bevacizumab [Avastin] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks<br>|
| Pegylated liposomal doxorubicin + bevacizumab<br> | Drug: Pegylated liposomal doxorubicin<br>* Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks<br>Drug: Bevacizumab<br>* Drug: bevacizumab [Avastin] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | 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 | 36 months | 
| Incidence of Treatment-Emergent Adverse Events | 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. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Best Overall Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) by Modified RECIST until progression reported. Objective Response was determined by the investigator using modified RECIST criteria, Version 1.0. An objective response was a complete or partial overall confirmed response as determined by investigators. CR defined as complete disappearance of all target and non-target lesions and no new lesions. PR defined as greater than or equal to (≥) 30 percent (%) decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. | 36 months | 
| overall survival (OS) | Duration of overall survival was defined as the time from randomization to death of any cause. The OS data for participants for whom no death was captured in the clinical database were censored at the last time they were known to be alive. | 36 months |