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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00046787

Collaborator

OSI Pharmaceuticals (Industry)

Enrollment

Locations

Duration (Months)

4.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SCLC Carcinoma, Small Cell	Drug: OSI-211 (Liposomal Lurtotecan)	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2002

Actual Study Completion Date :

Feb 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

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