Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

PRIMARY OBJECTIVES: I. To determine the complete response rate of R115777 (tipifarnib) in previously untreated acute myeloid leukemia (AML) in (a) elderly patients (age \>= 75) and (b) patients (age \>= 65) with AML preceded by myelodysplastic syndrome (MDS), using a chronic dosing schedule. SECONDARY OBJECTIVES: I. To determine progression-free and overall survival in patients with previously untreated AML treated with R115777, using a chronic dosing schedule. II. To determine the duration of response in patients with previously untreated AML treated with R115777, using a chronic dosing schedule. III. To determine the effect of R115777 on the phosphorylation of mitogen-activated protein kinase (MAPK) and phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K) in leukemic cells. IV. To determine the effect of R115777 on processing of the farnesylated protein HDJ-2. V. To determine the toxicities of R115777 when given in a chronic dosing schedule. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily on days 1-21. Patients with a complete or partial response, hematologic improvement, or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response after the second course of therapy receive 2 additional courses of therapy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 125 patients will be accrued for this study within 11-17 months.