Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00093470

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Drug: tipifarnib Procedure: observation	Phase III

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Tipifarnib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease-free survival (DSD) measured at years 1.17, 1.67, 2.17, 2.67, 3.17, and 3.67 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival at 1-2 years after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment:	139
Study Start Date:	August 2004
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Drug: tipifarnib Given orally
Arm II: No Intervention Patients undergo observation only.	Procedure: observation No intervention

Detailed Description:

OBJECTIVES:

Primary

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

Compare overall survival in patients treated with these regimens.
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.

PROJECTED ACCRUAL: A total of 139 patients (69-70 per treatment arm) will be accrued for this study within 3.5 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

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

Other

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 CONCURRENT THERAPY:

Biologic therapy

Prior autologous stem cell transplantation allowed
Prior allogeneic bone marrow transplantation allowed provided treatment did not take place during the current remission

Chemotherapy

See Disease Characteristics
Recovered from prior chemotherapy
Prior consolidation chemotherapy allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No concurrent hepatic enzyme-inducing anticonvulsants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093470

Show 212 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Selina M. Luger, MD	University of Pennsylvania
Investigator:	Jacob M. Rowe, MD	Rambam Health Care Campus
Investigator:	Mark R. Litzow, MD	Mayo Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

[No authors listed] E2902: A Phase III randomized study of farnesyl transferase inhibitor R115777 in acute myeloid leukemia patients in second or subsequent remission or in remission after primary induction failure or patients over age 60 in first remission. Clin Adv Hematol Oncol. 2007 Jan;5(1):13-4. No abstract available.

Study ID Numbers:	CDR0000387995, ECOG-E2902
Study First Received:	October 6, 2004
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00093470
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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 myeloid leukemia in remission
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)

adult acute myelomonocytic leukemia (M4)
adult acute monocytic leukemia (M5b)
adult erythroleukemia (M6a)
adult acute megakaryoblastic leukemia (M7)
refractory anemia with excess blasts in transformation
adult acute minimally differentiated myeloid leukemia (M0)
recurrent adult acute myeloid leukemia

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Precancerous Conditions
Refractory anemia
Acute myelomonocytic leukemia
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Leukemia
Preleukemia
Anemia, Refractory
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute myelocytic leukemia
Tipifarnib

Myelodysplastic syndromes
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Anemia
Acute myelogenous leukemia
Leukemia, Myeloid
Recurrence
Leukemia, Myelomonocytic, Acute
Leukemia, Erythroblastic, Acute
Anemia, Refractory, with Excess of Blasts
Bone Marrow Diseases
Acute monoblastic leukemia

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type

Antineoplastic Agents
Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009