Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of the combination of erlotinib (erlotinib hydrochloride) and quinacrine (quinacrine dihydrochloride) in patients with advanced non-small-cell lung cancer. II. To determine the recommended Maximum Tolerated Dose (MTD) of the combination of erlotinib and quinacrine in patients with advanced non-small-cell lung cancer. SECONDARY OBJECTIVES: I. To describe the dose limiting toxicity of the erlotinib and quinacrine combination. II. To determine the pharmacokinetic profile of the erlotinib and quinacrine combination. III. To determine objective response rate (complete response \[CR\]+partial response \[PR\]) and clinical benefit rate (CR+PR+ stable disease \[SD\]) of the erlotinib and quinacrine combination. IV. To estimate overall survival (OS) OUTLINE: This is a phase I, dose escalation study of quinacrine dihydrochloride Escalation Portion: Patients receive erlotinib hydrochloride orally (PO)daily on days 1-28 and quinacrine dihydrochloride PO thrice daily (TID) on days, 1-7 and PO daily from days 8-28. After Maximum Tolerated Dose is established: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive erlotinib hydrochloride PO daily on days 1-28. ARM II: Patients receive erlotinib hydrochloride PO and quinacrine dihydrochloride PO daily (TID) on days, 1-7 and PO daily from days 8-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.