Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer

Astellas Pharma Inc80 enrolled

Overview

The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Neoplasms

Interventions

OSI-211 (Liposomal Lurtotecan)DRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed relapsed ovarian cancer. * Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm on spiral CT scan). * One or two prior regimens of chemotherapy. At least one regimen must have contained cisplatin or carboplatin. * At least three weeks since prior chemotherapy and recovery from any related toxicities. * At least four weeks since prior radiotherapy and recovery from any related toxicities.

Locations (11)

NYU- Kaplan Comprehensive Cancer Center

New York, New York, United States

The Sarah Cannon Cancer Center, Centennial Medical Center

Nashville, Tennessee, United States

St Chad's Unit

Birmingham, United Kingdom

Data from ClinicalTrials.gov

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