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

Ovarian Cancer Clinical Trial

— REBECA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367182
• Other study ID #: 4-2017-0748
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who have histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer.

2. Patients who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen)

3. 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:

1. Patients with previous treatment with bevacizumab.

2. Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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