Gemcitabine and R115777 (Tipifarnib) Combination Therapy for Metastatic Breast Cancer
I. Determine the objective response rate in women with metastatic breast cancer treated with
tipifarnib and gemcitabine.
II. Determine the duration of response and time to disease progression in patients treated
with this regimen.
OUTLINE: This is a multicenter phase I, dose-finding study of tipifarnib, followed by a
phase II study.
PHASE I: Patients receive oral tipifarnib twice daily on days 1-14 and gemcitabine IV over
30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive 1 of 2 doses of tipifarnib to determine a safe tolerable
dose. A safe tolerable dose is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity.
PHASE II: Patients receive tipifarnib as in phase I (at the dose established in phase I) and
gemcitabine as in phase I.
Patients are followed at 3 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate measured
Up to 5 years
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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