Study of OSI-211 Vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer - Full Text View

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

This study has been completed.

Sponsored by:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
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

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Gi 147211 Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:	80
Study Start Date:	September 2002
Estimated 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
	Royal Marsden NHS Trust
	London, United Kingdom, SW3 6JJ
	CRC Department of Medical Oncology
	Sutton Surrey, United Kingdom, SM2 5PT
	St Chad's Unit
	Birmingham, United Kingdom, B18 7QH
	Taunton & Somerset Hospital
	Taunton, United Kingdom, TA1 5DA
	Mount Vernon Hospital
	Northwood Middlesex, United Kingdom, HA6 2RN
	Royal Surrey County Hospital
	Guildford, Surrey, United Kingdom, GU2 7XX
	Northern Centre for Cancer Research, Newcastle General Hospital
	Newcastle upon Tyne, United Kingdom, NE4 6BE
	Medical Oncology Unit, Torbay District General Hospital
	Torquay, United Kingdom, TQ2 7AA
	Beatson Oncology Centre
	Glasgow, United Kingdom, G11 6NT

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Study ID Numbers:	110-20
First Received:	October 3, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00046800
Health Authority:	United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:

Ovarian Cancer

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Lurtotecan

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Ovarian Diseases

Ovarian epithelial cancer

Recurrence

Genital Diseases, Female

Endocrinopathy

Topotecan

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on October 07, 2008