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

This study has been completed.

First Received on October 3, 2002. Last Updated on October 18, 2011 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	OSI Pharmaceuticals
Information provided by (Responsible Party):	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00046800

Purpose

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Topotecan hydrochloride Topotecan Gi 147211

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046800

Locations

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

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00046800 History of Changes
Other Study ID Numbers:	110-20
Study First Received:	October 3, 2002
Last Updated:	October 18, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Ovarian Cancer

Additional relevant MeSH terms:

Neoplasms
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
Topotecan
Lurtotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012