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

This study has been completed.

Sponsor:

Collaborator:

OSI Pharmaceuticals

Information provided by (Responsible Party):

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00046787

First received: October 3, 2002

Last updated: October 18, 2011

Last verified: October 2011

History of Changes

Purpose

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	Intervention	Phase
SCLC Carcinoma, Small Cell	Drug: OSI-211 (Liposomal Lurtotecan)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment:	47
Study Start Date:	September 2002
Study Completion Date:	February 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046787

Locations

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

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00046787 History of Changes
Other Study ID Numbers:	110-12
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:

Small Cell Lung Cancer

Additional relevant MeSH terms:

Carcinoma, Small Cell
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lurtotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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