A Feasibility Study of Gemcitabin and Bevacizumab in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Trial ID #	UMIN000016619
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, Gemcitabine
Eligible Participant	Platinum resistant ovarian cancer with 1-3 prior platinum regimens, no prior bevacizumab
Patients Enrolled	19 patients, median 1 prior therapy (1-2); 12 Pt-S, 7 Pt-Rf
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 42% (3CR, 5PR, n=19) DCR: 84% (3CR, 5PR, 8SD, n=19) PFS: 5.1 months OS: 21.3 months
Clinically Significant Adverse Events	Serious AE: 1 patient w/ pulmonary embolism Grade 3-4 AE: decreased neutrophils (47%), proteinuria (21%), hypertension (16%), anemia (11%), nausea (11%)
Conclusion	The combination chemotherapy with gemcitabine and bevacizumab is feasible, effective and safe
Reference	Nagao S et al. A phase II study of the combination chemotherapy of bevacizumab and gemcitabine in women with platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Ovarian Res (2020) 13(1):14 https://pubmed.ncbi.nlm.nih.gov/32028974/