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

Primary Purpose

Ovarian Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OSI-211 (Liposomal Lurtotecan)
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU- Kaplan Comprehensive Cancer Center
  • The Sarah Cannon Cancer Center, Centennial Medical Center
  • St Chad's Unit
  • Beatson Oncology Centre
  • Royal Surrey County Hospital
  • Royal Marsden NHS Trust
  • Northern Centre for Cancer Research, Newcastle General Hospital
  • Mount Vernon Hospital
  • CRC Department of Medical Oncology
  • Taunton & Somerset Hospital
  • Medical Oncology Unit, Torbay District General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2002
Last Updated
October 18, 2011
Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00046800
Brief Title
Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
Official Title
A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
Keywords
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OSI-211 (Liposomal Lurtotecan)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
NYU- Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Sarah Cannon Cancer Center, Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
St Chad's Unit
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Beatson Oncology Centre
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford, Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Northern Centre for Cancer Research, Newcastle General Hospital
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood, Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
CRC Department of Medical Oncology
City
Sutton Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Taunton & Somerset Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Medical Oncology Unit, Torbay District General Hospital
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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