RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
75 milligrams per meter squared intraveneously
350 milligrams intraveneously
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil
Time frame: 28 weeks
To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil
Time frame: 28 weeks
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Palmetto Hematology/Oncology Associates
Spartanburg, South Carolina, United States
Massey Cancer Center
Richmond, Virginia, United States