Trials / Completed
CompletedNCT00077363
Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients With Metastatic Breast Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tipifarnib | Given PO |
| DRUG | capecitabine | Given PO |
Timeline
- Start date
- 2004-05-01
- Primary completion
- 2007-02-01
- First posted
- 2004-02-12
- Last updated
- 2013-02-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00077363. Inclusion in this directory is not an endorsement.