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

This study has been completed.

Sponsored by:	OSI Pharmaceuticals
Information provided by:	OSI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00046787

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 II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Gi 147211

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by OSI Pharmaceuticals:

Estimated Enrollment:	47
Study Start Date:	September 2002
Estimated 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
Vanderbilt Clinical Trials Office
Nashville, Tennessee, United States, 37232-6307
Baptist Hospital Regional Cancer Ctr.
Knoxville, Tennessee, United States, 37920
United Kingdom
Northern Centre for Cancer Research, Newcastle General Hospital
Newcastle upon Tyne, United Kingdom, NE4 6BE
Christie Hospital
Manchester, United Kingdom, M20 9BH
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Guys Hospital
London, United Kingdom, SE1
United Kingdom, Nottinghamshire
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
United Kingdom, Wirral
Clatterbridge Centre for Oncology
Bebington, Wirral, United Kingdom, CH63 4JY

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	110-12
Study First Received:	October 3, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00046787
Health Authority:	United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:

Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Lurtotecan
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009