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

Astellas

Status and phase: Completed; Phase 2

Conditions: SCLC; Carcinoma, Small Cell

Treatments: Drug: OSI-211 (Liposomal Lurtotecan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00046787

110-12

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)