A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients Over Age 60 in First Remission
A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients Over Age 60 in First Remission
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.
Inclusion Criteria:
Patients eligible to enter this study must fall into one of these categories:
Patients must be in complete remission (CR) or morphologic remission (MR) by blood counts and bone marrow studies to enter the study
Patients must have morphologic proof (from bone marrow aspirate, smears or touch preps of marrow biopsy) that they had AML of one of the following types prior to achievement of CR/MR
Patients with acute promyelocytic leukemia (FAB M3) are not eligible
Patients must be registered within 60 days of completion of therapy for the current remission; patients are eligible if they meet any of the criteria below:
All of the patients below are eligible for study entry:
Patients who have received an allogeneic transplant (bone marrow transplant [BMT] or peripheral stem cell transplant [PSCT]) in their current remission are ineligible; patients who have had an allogeneic transplant in a previous remission and are currently in remission after subsequent relapse are eligible
Patients with a history of extramedullary disease are eligible if they are in complete remission at the time of study entry and no longer requiring therapy for their extramedullary disease
Patients must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study < 2 weeks prior to randomization to rule out pregnancy
Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
Patients must not be known to have an allergy to imidazole drugs, such as clotrimazole ketoconazole, miconazole, econazole, or terconazole; this does not include fluconazole, voriconazole, or itraconazole
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
Patients must not have active cardiac or pulmonary disease; but patient will be eligible if disease is medically controlled
Patients must not have active renal disease; creatinine must be =< 1.5 x upper limit of normal
Patients must not have active hepatic disease; total or direct bilirubin must be < 2 mg/dl
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) must be =< 2.5 times the upper limit of normal
Absolute neutrophil count (ANC) >= 1000/mm^3
Platelet count >= 50,000/mm^3
Patients must not be taking a hepatic enzyme-inducing anti-convulsant; a patient will not be eligible for the study if the patient is currently taking one of these agents and cannot be switched to a non-hepatic enzyme-inducing anti-convulsant
Miami, Florida 33136, United States
Pekin, Illinois 61554, United States
Houma, Louisiana 70360, United States
Shreveport, Louisiana 71103, United States
East Syracuse, New York 13057, United States
Houston, Texas 77030, United States
Berlin Corners, Vermont 05602, United States