Solid Neoplasm Clinical Trial
Official title:
Phase I Trial of R115777 and OSI-774 in Patients With Advanced Solid Tumors
This phase I trial studies the side effects and best dose of tipifarnib and erlotinib hydrochloride in treating patients with solid tumors that have spread to other places in the body. Tipifarnib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the maximal tolerated dose of R115777 (tipifarnib) in combination with
OSI-774 (erlotinib hydrochloride).
II. To describe the toxicity profile of this combination. III. To evaluate the effect of
OSI-774 on the disposition of R115777. IV. To evaluate in vitro markers of farnesyl
transferase (FT) inhibition and epidermal growth factor receptor (EGFR) inhibition.
OUTLINE: This is a dose-escalation study.
Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-28 (days 8-28
of course 1 as of 11/4/2013) and tipifarnib PO twice daily (BID) on days 1-21. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity. (Closed to
accrual as of 2/2/06)
After completion of study treatment, patients are followed up at 3 months.
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