drugset / Trial / NCT01462890
Evaluation of Optimal Treatment Duration of Bevacizumab Combination With Standard Chemotherapy in Patients With Ovarian Cancer
Phase 3
Completed
927 enrolled
AGO Study Group
ARCAGY/ GINECO GROUP · collabNordic Society of Gynaecological Oncology - Clinical Trials Unit · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-11
- Primary completion
- 2020-12-31
- Completion
- 2021-12
Outcome
Missed primary endpoint
paper There was no difference in PFS between treatment arms (hazard ratio, 0.99; 95% CI, 0.85 to 1.15; unstratified log-rank P = .90). PMID 36332161 ↗
Publications
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- Pfisterer J, Joly F, Kristensen G, Rau J, Mahner S, Pautier P, El-Balat A, Kurtz JE, Canzler U, Sehouli J, Heubner ML, Hartkopf AD, Baumann K, Hasenburg A, Hanker LC, Belau A, Schmalfeldt B, Denschlag D, Park-Simon TW, Selle F, Jackisch C, Burges A, Luck HJ, Emons G, Meier W, Gropp-Meier M, Schroder W, de Gregorio N, Hilpert F, Harter P. Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial. J Clin Oncol. 2023 Feb 1;41(4):893-902. doi: 10.1200/JCO.22.01010. Epub 2022 Nov 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |