A Randomized Phase II Evaluation of Weekly Paclitaxel (NSC# 673089) versus Weekly Paclitaxel with Oncolytic Reovirus (Reolysin NSC # 729968, BB-IND #13370) in the Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Principal Investigator
David Cohn, MD
Status
Terminated
Date Opened To Accrual
December 06 2010
Date Closed to Accrual
September 02 2014
Date of Study Termination
July 17 2020
Disease Site
Gynecologic [GY]
Ovarian
Phase
II
Developmental Therapeutics
No
Primary Objective
To estimate the progression-free survival hazard ratio of the combination
of weekly paclitaxel with Reolysin® to weekly paclitaxel alone in patients
with persistent or recurrent ovarian, fallopian tube, or primary peritoneal
cancer.
To determine the frequency and severity of adverse events associated with
treatment with weekly paclitaxel alone and weekly paclitaxel with
REOLYSIN® as assessed by CTCAE.
Patient Population
Patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal
cancer.
Target Accrual
110
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.