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

This study has been completed.
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00046800
First received: October 3, 2002
Last updated: October 18, 2011
Last verified: October 2011

October 3, 2002
October 18, 2011
September 2002
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Complete list of historical versions of study NCT00046800 on ClinicalTrials.gov Archive Site
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Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
Drug: OSI-211 (Liposomal Lurtotecan)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2003
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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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00046800
110-20
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
OSI Pharmaceuticals
Not Provided
Astellas Pharma Inc
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP