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

October 18, 2011 updated by: Astellas Pharma Inc

A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • St Chad's Unit
      • Glasgow, United Kingdom, G11 6NT
        • Beatson Oncology Centre
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Royal Surrey County Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust
      • Newcastle-upon-Tyne, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Research, Newcastle General Hospital
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
      • Sutton Surrey, United Kingdom, SM2 5PT
        • CRC Department of Medical Oncology
      • Taunton, United Kingdom, TA1 5DA
        • Taunton & Somerset Hospital
      • Torquay, United Kingdom, TQ2 7AA
        • Medical Oncology Unit, Torbay District General Hospital
  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU- Kaplan Comprehensive Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Cancer Center, Centennial Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

OSI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

October 3, 2002

First Posted (Estimate)

October 4, 2002

Study Record Updates

Last Update Posted (Estimate)

October 20, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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