Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
OBJECTIVES:
- Determine the response rate in women with locally unresectable or metastatic breast
cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or
third-line chemotherapy.
- Evaluate the toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and leucovorin calcium IV over 1 hour
followed by fluorouracil IV over 5 minutes on days 1-3. Treatment repeats every 4 weeks for
2-8 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 44
months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
28 weeks
No
Gretchen Kimmick, MD, MS
Study Chair
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
CDR0000068567
NCT00015886
January 1997
July 2009
Name | Location |
---|---|
East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Cancer Centers of the Carolinas | Greenville, South Carolina 29605 |
Palmetto Hematology/Oncology Associates | Spartanburg, South Carolina 29303 |
Southeastern Medical Oncology Center | Goldsboro, North Carolina 27534 |