Overview

This trial is active, not recruiting.

Conditions adult acute myeloid leukemia, adult acute myeloid leukemia in remission
Treatments clinical observation, tipifarnib
Phase phase 3
Sponsor National Cancer Institute (NCI)
Start date August 2004
End date February 2015
Trial size 144 participants
Trial identifier NCT00093470, E2902, NCI-2009-00535, U10CA021115, U10CA180820

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
tipifarnib R115777
Given PO
(Other)
Patients undergo observation only.
clinical observation
Undergo observation

Primary Outcomes

Measure
Disease-free Survival
time frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.

Secondary Outcomes

Measure
Overall Survival
time frame: Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients eligible to enter this study must fall into one of these categories: - Patients in first remission following primary induction failure and have received at least two chemotherapy induction regimens - Patients in second or subsequent remission - Patients > 60 years old in first remission - Patients must be in complete remission (CR) or morphologic remission (MR) by blood counts and bone marrow studies to enter the study - Confirmatory bone marrow must be performed =< 2 weeks prior to randomization - 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 - Acute myeloblastic leukemia, minimal differentiation (French-American-British [FAB] M0) - Acute myeloblastic leukemia without differentiation (FAB M1) - Acute myeloblastic leukemia with maturation (FAB M2) - Acute myelomonocytic leukemia (FAB M4) - Acute monocytic leukemia (FAB M5) - Acute erythroleukemia (FAB M6) - Acute megakaryocytic leukemia (FAB M7) - Refractory anemia with excess blasts in transformation (RAEB-T) - AML by World Health Organization (WHO) criteria - Acute myeloid leukemia with multilineage dysplasia - Patients must be registered within 60 days of completion of therapy for the current remission - All of the patients below are eligible for study entry: - Patients who have received consolidation therapy - Patients who have not received any consolidation or post remission therapy - Patients who have had an autologous stem cell transplant - 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 - Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) >= 1000/mm^3 - Platelet count >= 50,000/mm^3 Exclusion Criteria: - Patients with acute promyelocytic leukemia (FAB M3) - 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 - Pregnant or breast-feeding - Allergy to imidazole drugs, such as clotrimazole ketoconazole, miconazole, econazole, or terconazole; this does not include fluconazole, voriconazole, or itraconazole - Active cardiac or pulmonary disease; but patient will be eligible if disease is medically controlled - Active renal disease - Active hepatic disease - Patients who are taking a hepatic enzyme-inducing anti-convulsant

Additional Information

Official title 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
Description PRIMARY OBJECTIVES: I. To compare R115777 (tipifarnib) maintenance therapy to observation only with respect to disease-free survival (DFS) in patients with acute myeloid leukemia (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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).