AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Inclusion Criteria:

* Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
* SCLC that is either sensitive (defined as a response including stable disease to first-line platinum-based chemotherapy, with subsequent progression \>/= 90 days after completing first-line chemotherapy) or refractory (defined as best response to first-line platinum-based chemotherapy or progression \< 90 days after completing first-line chemotherapy);
* Extensive or limited disease; patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
* Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
* No more than 1 prior chemotherapy regimen;
* At least 18 years of age;
* ECOG performance status of 0 - 1

Exclusion Criteria:

* Chest radiotherapy with curative intent to the primary disease complex \</= 28 days prior to first dose; CNS radiotherapy \</= 21 days prior to first dose; radiotherapy to all other areas \</= 7 days prior to first dose;
* Prior anthracycline, topotecan, or irinotecan treatment.
* Prior anthracycline or topotecan treatment.
* Patients with know history of seropositive human immunodeficiency virus (HIV) or patients who are receiving immunosuppressive medications that would increase the risk of serious neutropenic complications