Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer
- Determine the response rate in women with locally unresectable or metastatic breast
cancer treated with docetaxel, leucovorin calcium, and fluorouracil as second or
- 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
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
Gretchen Kimmick, MD, MS
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|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|