Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer
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.
Interventions
DRUGdocetaxel
75 milligrams per meter squared intraveneously
DRUGfluorouracil
350 milligrams intraveneously
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic or unresectable local disease * Measurable or evaluable disease * No ascites or pleural effusion as only metastatic site * No brain or leptomeningeal metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * 0-2 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count greater than 1,500/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin normal * SGOT/SGPT less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * Adequate cardiac function * No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina) * No history of significant cardiac arrhythmia Other: * No serious medical or psychiatric illness that would preclude study * No active uncontrolled bacterial, viral, or fungal infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior high-dose chemotherapy and autologous transplantation Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy) * No prior docetaxel * No prior high-dose chemotherapy and autologous transplantation * Prior paclitaxel allowed Endocrine therapy: * No concurrent hormonal therapy, except as contraception Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered * Concurrent radiotherapy for relief of localized pain or obstruction allowed Surgery: * At least 2 weeks since prior major surgery and recovered Other: * No other concurrent cytotoxic agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil | 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil | 28 weeks |
Countries
United States
Outcome results
None listed