Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer
This study has been completed.
Sponsor:
Astellas Pharma Inc
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
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046800
Locations
| 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 | |
| St Chad's Unit | |
| Birmingham, United Kingdom, B18 7QH | |
| Beatson Oncology Centre | |
| Glasgow, United Kingdom, G11 6NT | |
| Royal Surrey County Hospital | |
| Guildford, Surrey, United Kingdom, GU2 7XX | |
| Royal Marsden NHS Trust | |
| London, United Kingdom, SW3 6JJ | |
| Northern Centre for Cancer Research, Newcastle General Hospital | |
| Newcastle-upon-Tyne, United Kingdom, NE4 6BE | |
| Mount Vernon Hospital | |
| Northwood, Middlesex, United Kingdom, HA6 2RN | |
| CRC Department of Medical Oncology | |
| Sutton Surrey, United Kingdom, SM2 5PT | |
| Taunton & Somerset Hospital | |
| Taunton, United Kingdom, TA1 5DA | |
| Medical Oncology Unit, Torbay District General Hospital | |
| Torquay, United Kingdom, TQ2 7AA | |
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00046800 History of Changes |
| Other Study ID Numbers: | 110-20 |
| Study First Received: | October 3, 2002 |
| Last Updated: | October 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Ovarian Cancer |
Additional relevant MeSH terms:
|
Neoplasms Ovarian Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Neoplasms by Histologic Type Topotecan Lurtotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013