A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

Trial ID #	NCT03093155
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	Bevacizumab, Ixabepilone
Eligible Participant	Platinum resistant, refractory or persistent ovarian cancer; median 3 prior therapies; 18% Pt-Rf, 55% w/ prior Bev
Patients Enrolled	78
Therapy Setting	Recurrence
Study Design	Open-Label, Randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Efficacy	Bev+Ixa (n=39) vs Ixa (n=37): ORR: 33 vs 8%, p=0.004 PFS: 5.5 vs 2.2 months, HR: 0.33 (0.19-0.55, p<0.001) OS: 10.0 vs 6.0 months, HR: 0.52 (0.31-0.87, p=0.006)
Clinically Significant Adverse Events	Serious AE: 1 bowel perforation in Ixa+Bev arm Grade 3-4 AE:
Conclusion	Bevacizumab+ixabepilone is a well-tolerated, effective combination for treatment of platinum/taxane resistant ovarian cancer that extends both PFS/OS relative to ixabepilone monotherapy and prior receipt of bevacizumab should not preclude use of ixabepilone+bevacizumab
Reference	Roque DM et al. Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer. Br J Cancer (2022) 126(12):1695-1703 https://pubmed.ncbi.nlm.nih.gov/35149854/