Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase I Study of Erlotinib in Combination With Quinacrine in Patients With Advanced Non-Small-Cell Lung Cancer
This phase I trial studies the side effects and best dose of quinacrine dihydrochloride when given together with erlotinib hydrochloride and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as quinacrine dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib hydrochloride together with quinacrine dihydrochloride may kill more tumor cells
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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