Clinical Trials Directory

Trials / Completed

CompletedNCT01462890

Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer

A Prospective Randomised Phase III Trial to Evaluate Optimal Treatment Duration of First-line Bevacizumab in Combination With Carboplatin and Paclitaxel in Patients With Primary Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
927 (actual)
Sponsor
AGO Study Group · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months.

Detailed description

Determination whether the early and continuous addition of bevacizumab for up to 30 months to the standard chemotherapy is more effective than the early and continuous addition of bevacizumab for up to 15 months

Conditions

Interventions

TypeNameDescription
BIOLOGICALBevacizumab15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44
DRUGPaclitaxel175 mg/m², iv on day 1 every 3 weeks for 6 cycles
DRUGCarboplatinAUC 5, iv on day 1 every 3 weeks for 6 cycles
OTHERspecialized pathology review (Germany only)before randomization

Timeline

Start date
2011-11-01
Primary completion
2020-12-31
Completion
2021-12-01
First posted
2011-11-01
Last updated
2022-07-20

Locations

131 sites across 6 countries: Denmark, Finland, France, Germany, Norway, Sweden

Source: ClinicalTrials.gov record NCT01462890. Inclusion in this directory is not an endorsement.