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Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00046787
Recruitment Status : Completed
First Posted : October 4, 2002
Last Update Posted : October 20, 2011
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.

Condition or disease Intervention/treatment Phase
SCLC Carcinoma, Small Cell Drug: OSI-211 (Liposomal Lurtotecan) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Determine the Efficacy of OSI-211 (Liposomal Lurtotecan) Given on Days 1, 2 & 3 Every 3 Weeks in Patients With Recurrent Small Cell Lung Cancer
Study Start Date : September 2002
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed recurrent small cell lung cancer.
  • One prior treatment of chemotherapy.
  • At least three weeks since last chemotherapy treatment and recovery from any related side effects.
  • At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects.
  • At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan).
  • If a patient has had previous documented Central Nervous System (CNS) involvement, only controlled disease is acceptable.

Exclusion Criteria:

  • Superior vena cava syndrome.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00046787

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United States, Arizona
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States, 85712
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Tennessee
Baptist Hospital Regional Cancer Ctr.
Knoxville, Tennessee, United States, 37920
Vanderbilt Clinical Trials Office
Nashville, Tennessee, United States, 37232-6307
United Kingdom
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Clatterbridge Centre for Oncology
Bebington, Wirral, United Kingdom, CH63 4JY
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Guys Hospital
London, United Kingdom, SE1
Christie Hospital
Manchester, United Kingdom, M20 9BH
Northern Centre for Cancer Research, Newcastle General Hospital
Newcastle-upon-Tyne, United Kingdom, NE4 6BE
Sponsors and Collaborators
Astellas Pharma Inc
OSI Pharmaceuticals
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Responsible Party: Astellas Pharma Inc Identifier: NCT00046787    
Other Study ID Numbers: 110-12
First Posted: October 4, 2002    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011
Keywords provided by Astellas Pharma Inc:
Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents