Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer

Trial ID #	NCT01091259
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, Irinotecan
Eligible Participant	Recurrent ovarian cancer with no limit on prior therapies
Patients Enrolled	29; median 5 prior therapies (1-12); 10 Pt-S, 19 Pt-R
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	CBR, ORR, DCR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 27.6% (8PR) CBR: 72.4% PFS: 6.8 months OS: 15.4 months Exploratory analysis, Pt- status, prior Bev: Pt-S (n=10): ORR: 40% (4 PR); DCR: 90% (4PR, 5SD) Pt-R (n=19): ORR: 21% (4 PR); DCR: 63.2% (4PR, 8SD) Prior Bev (n=12): ORR: 25% (3PR); DCR: 66.7% (3PR, 5SD)
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: diarrhea (17%), fatigue (10%), pain (10%)
Conclusion	Bevacizumab+irinotecan shows encouraging activity in heavily pre-treated platinum resistant patients, including those treated with topotecan and/or avastin
Reference	Musa F et al. Phase II study of irinotecan in combination with bevacizumab in recurrent ovarian cancer. Gynecol Oncol (2017) 144(2):279-284 https://www.ncbi.nlm.nih.gov/pubmed/27931751