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

October 18, 2011 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary
      • London, United Kingdom, SE1
        • Guys Hospital
      • Manchester, United Kingdom, M20 9BH
        • Christie Hospital
      • Newcastle-upon-Tyne, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Research, Newcastle General Hospital
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Nottingham City Hospital
    • Wirral
      • Bebington, Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center, Inc.
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Baptist Hospital Regional Cancer Ctr.
      • Nashville, Tennessee, United States, 37232-6307
        • Vanderbilt Clinical Trials Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

OSI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (ACTUAL)

February 1, 2003

Study Registration Dates

First Submitted

October 3, 2002

First Submitted That Met QC Criteria

October 3, 2002

First Posted (ESTIMATE)

October 4, 2002

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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