Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00093470
First received: October 6, 2004
Last updated: April 18, 2014
Last verified: April 2014

October 6, 2004
April 18, 2014
August 2004
June 2014   (final data collection date for primary outcome measure)
Disease-free survival [ Time Frame: From randomization until relapse or death from any cause, up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00093470 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: From randomization until death from any cause, up to 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Tipifarnib in Treating Patients With Acute Myeloid Leukemia in 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

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 acute myeloid leukemia. This randomized phase III trial is studying how well tipifarnib works compared to observation alone in preventing cancer recurrence in patients with acute myeloid leukemia.

PRIMARY OBJECTIVES:

I. Compare disease-free survival in patients with acute myeloid leukemia in second or subsequent complete remission or in first complete remission treated with tipifarnib as maintenance therapy vs observation alone.

SECONDARY OBJECTIVES:

I. Compare overall survival in patients treated with these regimens. II. Determine long-term safety and toxicity of tipifarnib in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to remission status (first complete remission [CR] vs > first CR) and prior treatment for the most current remission (consolidation therapy vs no therapy). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo observation only.

Patients are followed for up to 5 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts in Transformation
  • Drug: tipifarnib
    Given orally
    Other Names:
    • R115777
    • Zarnestra
  • Procedure: clinical observation
    Undergo observation
    Other Name: observation
  • Experimental: Arm I
    Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    Intervention: Drug: tipifarnib
  • Arm II
    Patients undergo observation only.
    Intervention: Procedure: clinical observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
139
Not Provided
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Morphologically confirmed acute myeloid leukemia (AML) of 1 of the following types:

    • Acute myeloblastic leukemia (M0, M1, or M2)
    • Acute myelomonocytic leukemia (M4)
    • Acute monocytic leukemia (M5)
    • Acute erythroleukemia (M6)
    • Acute megakaryocytic leukemia (M7)
    • Refractory anemia with excess blasts in transformation
    • AML with multilineage dysplasia
  • In complete remission (CR) or molecular remission (MR) by blood counts and bone marrow studies* AND meets 1 of the following criteria:

    • In first CR after primary induction failure
    • Must have received at least 2 induction chemotherapy regimens
    • In second or subsequent CR
    • In first remission AND > 60 years of age NOTE: *Patients with CR documented by hematologic parameters are eligible provided current bone marrow studies confirm CR
  • Patients must meet 1 of the following criteria:

    • Achieved remission within the past 60 days
    • Completed induction or post-remission therapy within the past 60 days
    • Achieved hematologic recovery from chemotherapy within the past 60 days
  • Extramedullary disease allowed if in CR and not requiring therapy
  • No acute promyelocytic leukemia (FAB M3)
  • Performance status:

    • ECOG 0-2
  • Hematopoietic:

    • Absolute neutrophil count >= 1,000/mm^3
    • Platelet count >= 50,000/mm^3
  • Hepatic:

    • Bilirubin < 2 mg/dL
    • AST and ALT =< 2.5 times upper limit of normal (ULN)
    • No active hepatic disease
  • Renal:

    • Creatinine =< 1.5 times ULN
    • No active renal disease
  • Cardiovascular:

    • No active uncontrolled cardiac disease
  • Pulmonary:

    • No active uncontrolled pulmonary disease
  • No known allergy to imidazole drugs* (e.g., clotrimazole, ketoconazole, miconazole, econazole, or terconazole)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception NOTE: * Excludes fluconazole, voriconazole, or itraconazole
  • Prior autologous stem cell transplantation allowed
  • Prior allogeneic bone marrow transplantation allowed provided treatment did not take place during the current remission
  • Recovered from prior chemotherapy
  • Prior consolidation chemotherapy allowed
  • No concurrent hepatic enzyme-inducing anticonvulsants
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00093470
NCI-2009-00535, NCI-2009-00535, E2902, E2902, E2902, U10CA021115
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Selina Luger Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP