Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
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.
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gemcitabine and R115777 Combination Therapy for Metastatic Breast Cancer|
- Objective response rate (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- Time to disease progression using RECIST [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- ORR, by type and extent of prior chemotherapy [ Time Frame: Up to 9 years ] [ Designated as safety issue: No ]
- Change in serum proteomic analysis [ Time Frame: Baseline to up to 9 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Experimental: Treatment (gemcitabine hydrochloride, tipifarnib)
Patients receive tipifarnib PO BID on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Gemcitabine Hydrochloride
Other Names:Drug: Tipifarnib
Other Names:Other: Laboratory Biomarker Analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100750
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Banu Arun||M.D. Anderson Cancer Center|