Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat Recurrent Small Cell Lung Cancer
- Conditions
- SCLCCarcinoma, Small Cell
- Registration Number
- NCT00046787
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
- Superior vena cava syndrome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Christie Hospital
🇬🇧Manchester, United Kingdom
Vanderbilt Clinical Trials Office
🇺🇸Nashville, Tennessee, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Nottingham City Hospital
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Baptist Hospital Regional Cancer Ctr.
🇺🇸Knoxville, Tennessee, United States
Clatterbridge Centre for Oncology
🇬🇧Bebington, Wirral, United Kingdom
Guys Hospital
🇬🇧London, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Northern Centre for Cancer Research, Newcastle General Hospital
🇬🇧Newcastle-upon-Tyne, United Kingdom