This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia (AML) in remission. Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML.
PRIMARY OBJECTIVES: I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with AML in second or subsequent complete remission or in complete response (CR) following primary induction failure. SECONDARY OBJECTIVES: I. To compare overall survival of patients in both arms. II. To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients undergo observation only. After completion of study treatment, patients are followed up for 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Undergo observation
Given PO
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Disease-free Survival
Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.
Time frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.
Overall Survival
Overall survival (OS) is defined as the time from randomization to death from any cause.
Time frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.
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Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Porter Adventist Hospital
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Presbyterian - Saint Lukes Medical Center - Health One
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SCL Health Saint Joseph Hospital
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