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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00046800 |
The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Neoplasms |
Drug: OSI-211 (Liposomal Lurtotecan) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open Label Phase II Study of OSI-211 Vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, New York | |
NYU- Kaplan Comprehensive Cancer Center | |
New York, New York, United States, 10016 | |
United States, Tennessee | |
The Sarah Cannon Cancer Center, Centennial Medical Center | |
Nashville, Tennessee, United States, 37203 | |
United Kingdom | |
Royal Marsden NHS Trust | |
London, United Kingdom, SW3 6JJ | |
CRC Department of Medical Oncology | |
Sutton Surrey, United Kingdom, SM2 5PT | |
St Chad's Unit | |
Birmingham, United Kingdom, B18 7QH | |
Taunton & Somerset Hospital | |
Taunton, United Kingdom, TA1 5DA | |
Mount Vernon Hospital | |
Northwood Middlesex, United Kingdom, HA6 2RN | |
Royal Surrey County Hospital | |
Guildford, Surrey, United Kingdom, GU2 7XX | |
Northern Centre for Cancer Research, Newcastle General Hospital | |
Newcastle upon Tyne, United Kingdom, NE4 6BE | |
Medical Oncology Unit, Torbay District General Hospital | |
Torquay, United Kingdom, TQ2 7AA | |
Beatson Oncology Centre | |
Glasgow, United Kingdom, G11 6NT |
Study ID Numbers: | 110-20 |
Study First Received: | October 3, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00046800 |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Lurtotecan Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms |
Ovarian Diseases Ovarian epithelial cancer Recurrence Genital Diseases, Female Endocrinopathy Topotecan Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Adnexal Diseases |