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

Primary Purpose

SCLC, Carcinoma, Small Cell

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
OSI-211 (Liposomal Lurtotecan)
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for SCLC focused on measuring Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Clinical Research Center, Inc.
  • University of Colorado Health Sciences Center
  • Baptist Hospital Regional Cancer Ctr.
  • Vanderbilt Clinical Trials Office
  • Nottingham City Hospital
  • Clatterbridge Centre for Oncology
  • Aberdeen Royal Infirmary
  • Guys Hospital
  • Christie Hospital
  • Northern Centre for Cancer Research, Newcastle General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2002
Last Updated
October 18, 2011
Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00046787
Brief Title
Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SCLC, Carcinoma, Small Cell
Keywords
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OSI-211 (Liposomal Lurtotecan)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Baptist Hospital Regional Cancer Ctr.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Vanderbilt Clinical Trials Office
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
Country
United Kingdom
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 9BH
Country
United Kingdom
Facility Name
Northern Centre for Cancer Research, Newcastle General Hospital
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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