Trial intelligence / Profile preview

N-Acetylcysteine and Topotecan in Recurrent Ovarian Cancer

NCT02569957Phase 2

Key facts

Status: Terminated
Start: Oct 2015
Primary completion: Jun 2016
Countries: 1
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Modality: Small Molecules

Drugs: acetylcysteine
Conditions: ovarian carcinomafallopian tube carcinoma (PFTC)primary peritoneal carcinoma (PPC)

Overview

Phase 2, randomised, open-label trial of acetylcysteine in ovarian carcinoma, fallopian tube carcinoma (PFTC) and primary peritoneal carcinoma (PPC) (2 arms), sponsored by Sidney Kimmel Comprehensive Cancer Center. Primary endpoint: Proportion of Patients Who Demonstrate a Downregulation of MCT4 at Day 20. Started Oct 2015; status: terminated.

Design

2 arms

Study design: RandomizedOpen-label

Topotecan Alone
Topotecan Hydrochloride IV
Topotecan + NAC
Topotecan Hydrochloride IV + Acetylcysteine IV and PO

Who it enrols

Patients with persistent or recurrent high grade endometrioid or serous ovarian, primary peritoneal or fallopian tube carcinoma who are platinum resistant and have received at least one prior platinum/taxane regimen but no more than 4 prior chemotherapy regimens.

Endpoints

Primary

Proportion of Patients Who Demonstrate a Downregulation of MCT4Day 20

Secondary

Change in Expression Levels of Cav-1 in Tissue SamplesDay 20
Change in Expression Levels of MCT1 in Tissue SamplesDay 20
Change in Expression Levels of TOMM20 in Tissue SamplesDay 20
Change in Expression Levels of FABP4 in Tissue SamplesDay 20
Change in Expression Levels of HIF-1 Alpha in Tissue SamplesDay 20
Change in Expression Levels of NFkB in Tissue SamplesDay 20
Change in Number of Circulating Tumor CellsDay 29
Progression-free Survival24 months

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