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NCT00046800 Clinical Trial

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

Ovarian Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00046800
Other study ID # 110-20
Secondary ID
Status Completed
Phase Phase 2
First received October 3, 2002
Last updated October 18, 2011
Start date September 2002
Est. completion date March 2003

Study information
Verified date October 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• OSI-211 (Liposomal Lurtotecan)

Locations
Country Name City State
United Kingdom 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 States The Sarah Cannon Cancer Center, Centennial Medical Center Nashville Tennessee
United States NYU- Kaplan Comprehensive Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

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