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

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Key information

Conditions

Ovarian Neoplasms Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

St Chad's Unit, Birmingham, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OSI-211 (Liposomal Lurtotecan)

Drug

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

OSI Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2002
Study completion: 2003
First posted: Oct 4, 2002
Registry last updated: Oct 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed