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OpenTrials
Completed

NCT Number: NCT03367182

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Severance hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  1. Response rate

    Time frame: 36 months

    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.

  2. overall survival (OS)

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: REBECA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2017
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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