NCT00100750

Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer

Gemcitabine and R115777 Combination Therapy for Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Breast Carcinoma
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine Hydrochloride	Given IV
DRUG	Tipifarnib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-10-01
• Completion: 2010-01-01
• First posted: 2005-01-07
• Last updated: 2015-01-13

Locations

1 site across 1 country: United States