A Phase I Study of Carboplatin/Paclitaxel/CTEP-Supplied Bevacizumab(NSC #704865, IND #7921)and CTEP-Supplied Agent ABT-888(NSC #737664,IND# 77840)in Newly Diagnosed Patients with Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary PeritCancer
Principal Investigator
Kathleen Moore, MD, MS
Status
Terminated
Date Opened To Accrual
October 28 2009
Date Closed to Accrual
August 01 2017
Date of Study Termination
April 10 2020
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.