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

Tracking Information
First Received Date ^ICMJE	October 3, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00046800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of OSI-211 Vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
Official Title ^ICMJE	A Randomized, Open Label Phase II Study of OSI-211 Vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
Brief Summary	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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Ovarian Neoplasms
Intervention ^ICMJE	Drug: OSI-211 (Liposomal Lurtotecan)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	March 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00046800
Responsible Party
Study ID Numbers ^ICMJE	110-20
Study Sponsor ^ICMJE	OSI Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	OSI Pharmaceuticals
Verification Date	June 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP