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

This study has been completed.
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: October 3, 2002
Last updated: October 18, 2011
Last verified: October 2011
The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.

Condition Intervention Phase
Ovarian Neoplasms Drug: OSI-211 (Liposomal Lurtotecan) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 80
Study Start Date: September 2002
Study Completion Date: March 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00046800

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

Responsible Party: Astellas Pharma Inc Identifier: NCT00046800     History of Changes
Other Study ID Numbers: 110-20
Study First Received: October 3, 2002
Last Updated: October 18, 2011

Keywords provided by Astellas Pharma Inc:
Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on September 21, 2017