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

NCT ID: NCT03367182

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-01-31

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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Weekly paclitaxel + bevacizumab

Weekly paclitaxel

Intervention Type DRUG

Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle

Bevacizumab

Intervention Type DRUG

Drug: bevacizumab \[Avastin\] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Topotecan + bevacizumab

Topotecan

Intervention Type 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

Bevacizumab

Intervention Type DRUG

Drug: bevacizumab \[Avastin\] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Pegylated liposomal doxorubicin + bevacizumab

Pegylated liposomal doxorubicin

Intervention Type DRUG

Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks

Bevacizumab

Intervention Type DRUG

Drug: bevacizumab \[Avastin\] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Interventions

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Weekly paclitaxel

Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle

Intervention Type DRUG

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

Intervention Type DRUG

Pegylated liposomal doxorubicin

Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks

Intervention Type DRUG

Bevacizumab

Drug: bevacizumab \[Avastin\] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee JY, Park JY, Park SY, Lee JW, Kim JW, Kim YB, Jeong DH, Lee KB, Kim TH, Lee IH, Choi MC, Kim KH, Kim YM, Lee YJ, Kang S; KGOG Investigators; Pujade-Lauraine E. Real-world effectiveness of bevacizumab based on AURELIA in platinum-resistant recurrent ovarian cancer (REBECA): A Korean Gynecologic Oncology Group study (KGOG 3041). Gynecol Oncol. 2019 Jan;152(1):61-67. doi: 10.1016/j.ygyno.2018.10.031. Epub 2018 Nov 6.

Reference Type DERIVED
PMID: 30409490 (View on PubMed)

Other Identifiers

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4-2017-0748

Identifier Type: -

Identifier Source: org_study_id

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