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


Study Design

Open-Label, Non-randomized


CBR, ORR, DCR, PFS, OS, evaluated per RECIST


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%)


Bevacizumab+irinotecan shows encouraging activity in heavily pre-treated platinum resistant patients, including those treated with topotecan and/or avastin


Musa F et al. Phase II study of irinotecan in combination with bevacizumab in recurrent ovarian cancer. Gynecol Oncol (2017) 144(2):279-284

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