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

NCT00046800CompletedPHASE2INTERVENTIONAL

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.

Key Facts

Lead Sponsor

Astellas Pharma Inc

Enrollment

80

Start Date

2002-09-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

OSI-211 (Liposomal Lurtotecan)

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Locations

NYU- Kaplan Comprehensive Cancer Center, New York, United States

The Sarah Cannon Cancer Center, Centennial Medical Center, Nashville, United States

St Chad's Unit, Birmingham, United Kingdom

Beatson Oncology Centre, Glasgow, United Kingdom

Royal Surrey County Hospital, Guildford, Surrey, United Kingdom

Royal Marsden NHS Trust, London, United Kingdom

Northern Centre for Cancer Research, Newcastle General Hospital, Newcastle upon Tyne, United Kingdom

Mount Vernon Hospital, Northwood, Middlesex, United Kingdom

CRC Department of Medical Oncology, Sutton Surrey, United Kingdom

Taunton & Somerset Hospital, Taunton, United Kingdom

Medical Oncology Unit, Torbay District General Hospital, Torquay, United Kingdom

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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