A phase 1 dose-escalation study of intraperitoneal cisplatin, intravenous/intraperitoneal paclitaxel, bevacizumab, and olaparib for newly diagnosed ovarian cancer.

ABSTRACT:

Objective

We assessed the safety and maximum tolerated dose (MTD) of the poly ADP-ribose polymerase (PARP) inhibitor olaparib with intravenous (IV)/intraperitoneal (IP) cisplatin/paclitaxel and IV bevacizumab, followed by olaparib and bevacizumab maintenance, in patients with newly diagnosed ovarian cancer who had undergone primary debulking surgery.

Methods

Treatment included: (Cycles 1-6) Day 1, IV paclitaxel 135 mg/m²/3 h + (from Cycle 2 onward) bevacizumab 15 mg/kg; Day 2, IP cisplatin 75 mg/m²; Days 2-8, olaparib (50/100/200 mg BID); Day 8, IP paclitaxel 60 mg/m² of a 21-day cycle. Maintenance (Cycles 7-22) included: olaparib 300 mg BID and bevacizumab 15 mg/kg Day 1. The primary endpoint was MTD of olaparib, chemotherapy, and bevacizuma

SUBMITTER: Cadoo KA 

PROVIDER: S-EPMC7127949 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature