GOG-9923

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

Principal Investigator

Kathleen Moore, MD, MS

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

I

Developmental Therapeutics

No

Primary Objective

To determine the maximum tolerated dose (MTD) and dose-limiting toxicities of ABT-888 when administered using continuous versus intermittent dosing schedules with intravenous carboplatin, paclitaxel and bevacizumab using two different treatment regimens; or with intraperitoneal cisplatin and intravenous and intraperitonal paclitaxel and bevacizumab in women with newly diagnosed, previously untreated, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

To determine the feasibility of these treatment regimens over four cycles in a 2-stage group sequential design once the MTD is established.

To assess the toxicity of these regimens using the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Patient Population

Women with newly diagnosed, previously untreated, epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Target Accrual

300