Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:

Estimated Enrollment: 80
Study Start Date: September 2002
Study Completion Date: March 2003
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Lurtotecan
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014