NCT03367182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

November 29, 2017

Last Update Submit

January 10, 2019

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Response rate

    36 months

  • overall survival (OS)

    36 months

Study Arms (3)

Weekly paclitaxel + bevacizumab

Drug: Weekly paclitaxelDrug: Bevacizumab

Topotecan + bevacizumab

Drug: TopotecanDrug: Bevacizumab

Pegylated liposomal doxorubicin + bevacizumab

Drug: Pegylated liposomal doxorubicinDrug: Bevacizumab

Interventions

Weekly paclitaxelDRUG

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

Weekly paclitaxel + bevacizumab
TopotecanDRUG

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

Topotecan + bevacizumab
Pegylated liposomal doxorubicinDRUG

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

Pegylated liposomal doxorubicin + bevacizumab
BevacizumabDRUG

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

Pegylated liposomal doxorubicin + bevacizumabTopotecan + bevacizumabWeekly paclitaxel + bevacizumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with desease progression within 6 months of platinum treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with previous treatment with bevacizumab.
  • Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, 03722, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 30409490DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Topotecanliposomal doxorubicinBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 8, 2017

Study Start

September 1, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)