Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
|Recurrent Breast Carcinoma Stage IV Breast Cancer||Drug: Gemcitabine Hydrochloride Drug: Tipifarnib Other: Laboratory Biomarker Analysis||Phase 1 Phase 2|
|Study Design:||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 ]
- 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 ]
- Change in serum proteomic analysis [ Time Frame: Baseline to up to 9 years ]
|Study Start Date:||September 2005|
|Study Completion Date:||January 2010|
|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|