Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Docetaxel (Taxotere) and 5-Fluorouracil As Second- Or Third-Line Chemotherapy In Women With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: fluorouracil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|75 milligrams per meter squared intraveneously|
|Drug: fluorouracil|350 milligrams intraveneously|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil |  | 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil |  | 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer