Trial ID # | NCT01305213 |
Phase | II |
Drug Class | Angiogenesis Inhibitors: VEGF |
Drug Name | Bevacizumab |
Alternate Drug Names | immunoglobulin G1 (human-mouse monoclonal rhuMab-VEGF gamma-chain, anti-VEGF monoclonal antibody, Avastin |
Drugs in Trial | Fosbretabulin, Bevacizumab |
Eligible Participant | Recurrent or persistent ovarian, fallopian tube, and primary peritoneal cancer; ≤ 3 prior therapies |
Patients Enrolled | 107 |
Therapy Setting | Recurrence |
Study Design | Open-Label, Randomized |
Endpoints | ORR, PFS, OS, evaluated per RECIST |
Efficacy | Fos+Bev vs Bev: ORR: 35.7 vs 28.2% (p=0.24) Exploratory analysis Pt status: |
Clinically Significant Adverse Events | Fos+Bev vs Bev: |
Conclusion | Improved PFS with addition of fosbretabulin |
Reference | Monk BJ et al. Randomized Phase II Evaluation of Bevacizumab Versus Bevacizumab Plus Fosbretabulin in Recurrent Ovarian, Tubal, or Peritoneal Carcinoma: An NRG Oncology/Gynecologic Oncology Group Study. J Clin Oncol (2016) 34(19):2279-86 Tewari KS et al. Bevacizumab plus fosbretabulin in recurrent ovarian cancer: Overall survival and exploratory analyses of a randomized phase II NRG oncology/gynecologic oncology group study. Gynecol Oncol (2020) 159(1):79-87 |