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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: OSI Pharmaceuticals
• Treatments: Camptothecin; Lurtotecan

Criteria

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.