Breast Cancer Clinical Trial
Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
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.
Full 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.
Eligibility 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
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There are 6 Locations for this study
Goldsboro North Carolina, 27534, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27157, United States
Greenville South Carolina, 29605, United States
Spartanburg South Carolina, 29303, United States
Richmond Virginia, 23298, United States
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