Gemcitabine and R115777 Combination Therapy for Metastatic Breast Cancer

NCT00100750 Phase 1/Phase 2 COMPLETED

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.

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	31
Start date	2005-09
Completion	2010-01

Conditions

• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Interventions

• Gemcitabine Hydrochloride
• Tipifarnib
• Laboratory Biomarker Analysis

Primary outcomes

• Objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST) — Up to 9 years

Countries

United States