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

NCT ID: NCT00046787

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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SCLC Carcinoma, Small Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OSI-211 (Liposomal Lurtotecan)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OSI Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Clinical Research Center, Inc.

Tucson, Arizona, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Baptist Hospital Regional Cancer Ctr.

Knoxville, Tennessee, United States

Site Status

Vanderbilt Clinical Trials Office

Nashville, Tennessee, United States

Site Status

Nottingham City Hospital

Nottingham, Nottinghamshire, United Kingdom

Site Status

Clatterbridge Centre for Oncology

Bebington, Wirral, United Kingdom

Site Status

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

Guys Hospital

London, , United Kingdom

Site Status

Christie Hospital

Manchester, , United Kingdom

Site Status

Northern Centre for Cancer Research, Newcastle General Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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110-12

Identifier Type: -

Identifier Source: org_study_id