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

NCT ID: NCT00046800

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-03-31

Brief Summary

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

Detailed Description

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Conditions

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Ovarian Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OSI-211 (Liposomal Lurtotecan)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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OSI Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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NYU- Kaplan Comprehensive Cancer Center

New York, New York, United States

Site Status

The Sarah Cannon Cancer Center, Centennial Medical Center

Nashville, Tennessee, United States

Site Status

St Chad's Unit

Birmingham, , United Kingdom

Site Status

Beatson Oncology Centre

Glasgow, , United Kingdom

Site Status

Royal Surrey County Hospital

Guildford, Surrey, , United Kingdom

Site Status

Royal Marsden NHS Trust

London, , United Kingdom

Site Status

Northern Centre for Cancer Research, Newcastle General Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Mount Vernon Hospital

Northwood, Middlesex, , United Kingdom

Site Status

CRC Department of Medical Oncology

Sutton Surrey, , United Kingdom

Site Status

Taunton & Somerset Hospital

Taunton, , United Kingdom

Site Status

Medical Oncology Unit, Torbay District General Hospital

Torquay, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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110-20

Identifier Type: -

Identifier Source: org_study_id