Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
- Conditions
- Breast Cancer
- Registration Number
- NCT00015886
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil 28 weeks
- Secondary Outcome Measures
Name Time Method To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil 28 weeks
Trial Locations
- Locations (6)
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
Palmetto Hematology/Oncology Associates
🇺🇸Spartanburg, South Carolina, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Southeastern Medical Oncology Center🇺🇸Goldsboro, North Carolina, United States