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

Trial ID # NCT00989651; GOG-9923
Phase I
Drug Class DNA Damage Repair Pathway Inhibitors: PARP
Drug Name Veliparib
Alternate Drug Names ABT-888
Drugs in Trial Bevacizumab, Carboplatin, Cisplatin, Paclitaxel, Veliparib
Eligible Participant

Newly diagnosed stage II-IV ovarian cancer

Patients Enrolled

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

Therapy Setting

First-line

Study Design

Open-Label, Non-randomized

Endpoints

PFS, OS, evaluated per RECIST

Efficacy

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

Clinically Significant Adverse Events

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

Conclusion

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

Reference

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