Spots Global Cancer Trial Database for Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer

Study Description

Brief Summary: This phase II trial is studying how well giving capecitabine together with tipifarnib works in treating women with taxane-resistant metastatic breast cancer. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving capecitabine together with tipifarnib may kill more tumor cells

Detailed Description: PRIMARY OBJECTIVES: I. The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib. SECONDARY OBJECTIVES: I. To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib. II. To evaluate progression free survival, time to treatment failure, and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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