Phase 2 N=84 Randomized Treatment

Tipifarnib and Etoposide in Treating Older Patients With Newly Diagnosed, Previously Untreated Acute Myeloid Leukemia

Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome · Adult Acute Megakaryoblastic Leukemia (M7) · Adult Acute Minimally Differentiated Myeloid Leukemia (M0) · Adult Acute Monoblastic Leukemia (M5a) · Adult Acute Monocytic Leukemia (M5b)

Bottom Line

View on ClinicalTrials.gov: NCT00602771 ↗

Enrolled (actual)

Serious AEs

15.5%

Results posted

May 2014

Primary outcome: Primary: Complete Response — 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: tipifarnib (Drug); etoposide (Drug)
Age: Older Adult · 70+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Response	0; 0	—

Summary

This randomized phase II trial is studying the side effects and how well giving tipifarnib together with etoposide works in treating older patients with newly diagnosed, previously untreated acute myeloid leukemia. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tipifarnib together with etoposide may kill more cancer cells.

Eligibility Criteria

Criteria:

Pathologically confirmed newly diagnosed acute myeloid leukemia (AML)
Subtypes M0, M1, M2, M4-7 disease
No newly diagnosed acute promyelocytic leukemia (M3)
Any of the following diseases:
De novo disease
Secondary AML
Myelodysplasia (MDS)-related AML (MDS/AML)
Treatment-related AML
Previously untreated disease
Patients who have received prior hydroxyurea alone or non-cytotoxic therapies for MDS (e.g., thalidomide, interferon, cytokines, 5-azacytidine, or revlimid) will be eligible for this study
Must be considered ineligible for traditional antileukemia chemotherapy
No hyperleukocytosis with ≥ 30, 000 blasts/uL or rapidly rising blast count with projected doubling time of =< 2 days
Patients may receive hydroxyurea to lower blast count to < 30,000 blasts/uL up to 24 hours before beginning tipifarnib and etoposide
No active CNS leukemia
No prior tipifarnib or etoposide
No concurrent radiotherapy, immunotherapy, or other chemotherapy
No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine)
Patients may be changed to non-enzyme-inducing anticonvulsants and stabilized before starting study treatment

Inclusion Criteria

ECOG performance status 0-2
Serum creatinine =< 2.0 mg/dL
SGOT and SGPT =< 3 times upper limit of normal
Bilirubin =< 2 mg/dL

Exclusion Criteria

Active, uncontrolled infection
Patients with infection under active treatment and controlled with antimicrobials are eligible
Presence of other life-threatening illnesses
Patients with mental deficits and/or psychiatric history that preclude them from giving informed consent or from following protocol
Allergies to imidazoles (e.g., clotrimazole, ketoconazole, miconazole, or econazole)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00602771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.