This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with gemcitabine hydrochloride and to see how well they work in treating women with breast cancer that has spread to other parts of the body. Tipifarnib is a drug that binds to specific proteins on the tumor cells and then kills these cells. Gemcitabine hydrochloride is a chemotherapy drug that may kill tumor cells by preventing cells from dividing. Giving tipifarnib together with gemcitabine hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES: I. To evaluate the objective response rate of the combination of gemcitabine (gemcitabine hydrochloride) and the farnesyltransferase inhibitor tipifarnib (R115777) in patients with metastatic breast cancer. II. To evaluate the duration of response, time to disease progression in patients with metastatic breast cancer treated with the combination of gemcitabine and tipifarnib (R115777). OUTLINE: This is a phase I, dose-escalation study of tipifarnib followed by a phase II study. Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-14 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
M D Anderson Cancer Center
Houston, Texas, United States
Objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 9 years
Time to disease progression using RECIST
Time frame: Up to 9 years
Incidence of adverse events observed during treatment, graded using the Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days after completion of study treatment
ORR, by type and extent of prior chemotherapy
Time frame: Up to 9 years
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