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NCT00046787 Clinical Trial

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

SCLC Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00046787
Other study ID # 110-12
Secondary ID
Status Completed
Phase Phase 2
First received October 3, 2002
Last updated October 18, 2011
Start date September 2002
Est. completion date February 2003

Study information
Verified date October 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date February 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• OSI-211 (Liposomal Lurtotecan)

Locations
Country Name City State
United Kingdom Aberdeen Royal Infirmary Aberdeen
United Kingdom Clatterbridge Centre for Oncology Bebington Wirral
United Kingdom Guys Hospital London
United Kingdom Christie Hospital Manchester
United Kingdom Northern Centre for Cancer Research, Newcastle General Hospital Newcastle-upon-Tyne
United Kingdom Nottingham City Hospital Nottingham Nottinghamshire
United States University of Colorado Health Sciences Center Denver Colorado
United States Baptist Hospital Regional Cancer Ctr. Knoxville Tennessee
United States Vanderbilt Clinical Trials Office Nashville Tennessee
United States Arizona Clinical Research Center, Inc. Tucson Arizona

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc OSI Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

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