A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Newly diagnosed stage II-IV ovarian cancer

424 stage II-IV ovarian cancer (73.6% stage III)

First-line

Open-Label, Non-randomized

PFS, OS, evaluated per RECIST

IV: IV CarboPt+Pac+Bev every 21 days w/ Bev maint (n=173)
weekly IV: weekly IV Pac+CarboPt+Bev w/ Bev maint (n=128)
IP: IP CisPt + IV/IP Pac+Bev IV w/ Bev maint (n=123)
Veliparib is given with chemotherapy either as continuous treatment (Vel cont): twice daily for the entirety of each cycle or as intermittent treatment (Vel int): on days −2 to 5 of each cycle

IV Vel cont vs IV Vel int vs weekly IV Vel cont vs weekly IV Vel int vs IP Vel cont vs IP Vel int:
PFS: 24.5 vs 26.1 vs 23.5 vs 24.4 vs 43.2 vs 39.6 months
OS: 65.2 vs 59.9 vs 66.5 vs 67.2 vs NR vs NR months

IV vs weekly IV vs IP:
Serious AE:
Grade 4-5 AE: 85 vs 50 vs 45.5%

Patients receiving IP cisplatin + IV/IP paclitaxel show promising PFS and OS when compared to patients receiving IV carboplatin+paclitaxel, however differences may be reflective of selection bias toward patients enrolled on the IP chemotherapy arm

Washington CR et al. Outcomes based on treatment regimen in newly diagnosed ovarian, primary peritoneal and fallopian tube cancer receiving intravenous or intraperitoneal platinum-based chemotherapy in combination with veliparib and bevacizumab. SGO (2020) abstract 27
https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/14938

Gillen J et al. Tolerability and adverse events experienced by women with ovarian cancer treated with intravenous or intraperitoneal chemotherapy plus veliparib and bevacizumab based on BRCA status. SGO (2020) abstract 26
https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/14689

Moore KN et al. A phase I study of intravenous or intraperitoneal platinum based chemotherapy in combination with veliparib and bevacizumab in newly diagnosed ovarian, primary peritoneal and fallopian tube cancer. Gynecol Oncol (2020) 156(1):13-22
https://pubmed.ncbi.nlm.nih.gov/31708167