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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00046787

Enrollment

Registered

2002-10-04

Start date

2002-09-30

Completion date

2003-02-28

Last updated

2011-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Small Cell, SCLC

Keywords

Small Cell Lung Cancer

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.

Interventions

DRUGOSI-211 (Liposomal Lurtotecan)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026