Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy

The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Inclusion Criteria:

• Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
• Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
• Measurable disease per RECIST criteria.
• Adequate bone marrow, hepatic and renal function.

Exclusion Criteria:

• Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
• Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
• Known hypersensitivity to minocycline.
• History of serious cardiac disease that is not controlled.
• Serious eye conditions.
• Prior treatment with inhibitors of EGFR of any kind.