Efficacy and Safety Study of OSI-211 (Liposomal Lurtotecan) to Treat 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.

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Key information

Conditions

SCLC Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Small Cell Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nottingham City Hospital, Nottingham, Nottinghamshire, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OSI-211 (Liposomal Lurtotecan)

Drug

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

OSI Pharmaceuticals

Registry information

Official study 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

Important dates

Study start: 2002
Study completion: 2003
First posted: Oct 4, 2002
Registry last updated: Oct 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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