Trials / Completed

CompletedNCT00112853

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

A Phase I Trial of Oral Etoposide in Combination With the Farnesyltransferase Inhibitor R115777 (ZARNESTRA, Tipifarnib, NSC #702818, IND #58,359) in Elderly Adults With Newly Diagnosed Acute Myelogenous Leukemia (AML)

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 100 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 70 Years
Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of tipifarnib and etoposide in treating older patients with newly diagnosed 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

Detailed description

PRIMARY OBJECTIVES: I. To determine the feasibility, tolerability, and toxicities of administering a fixed dose of R115777 in combination with escalating doses of VP-16 in elderly adults ( = 70 years) with newly diagnosed, previously untreated acute myelogenous leukemia (AML). II. To determine the maximal tolerated dose (MTD) of R115777 + VP-16 combination, including the duration of R115777 administration, for future Phase II trials. III. To obtain preliminary descriptive data regarding the effects of R115777 + VP-16 on cell cycle progression and apoptosis in AML marrow cells. IV. To study mechanisms of leukemia cell resistance to R115777 in combination with etoposide. OUTLINE: This is a multicenter, dose-escalation study. Patients receive oral tipifarnib twice daily on days 1-14 OR 1-21 and oral etoposide once daily on days 1-3 and 8-10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) may receive up to 5 additional courses of therapy beyond documentation of CR. Cohorts of 3-6 patients receive escalating doses of tipifarnib and etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 14 additional patients receive treatment at the MTD. After completion of study treatment, patients are followed at 1 month and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 3-100 patients will be accrued for this study.

Conditions

Interventions

Type	Name	Description
DRUG	tipifarnib	Given orally
DRUG	etoposide	Given orally

Timeline

Start date: 2005-03-01
Primary completion: 2009-05-01
First posted: 2005-06-03
Last updated: 2013-01-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00112853. Inclusion in this directory is not an endorsement.