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.

Condition	Treatment or Intervention	Phase
stage IIIB breast cancer stage IV breast cancer recurrent breast cancer	Procedure: chemotherapy  Drug: docetaxel  Drug: fluorouracil  Drug: leucovorin calcium	Phase II

Further Study Details: 

OBJECTIVES: I. 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. II. Evaluate the toxic effects of this regimen in these patients. III. Determine the time to progression in patients treated with this regimen.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      East Carolina University School of Medicine, Greenville,  North Carolina,  27858-4354,  United States
      Southeastern Medical Oncology Center, Goldsboro,  North Carolina,  27534,  United States
South Carolina
      Cancer Centers of the Carolinas, Greenville,  South Carolina,  29605,  United States
      Palmetto Hematology/Oncology Associates, Spartanburg,  South Carolina,  29303,  United States
Virginia
      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

Study chairs or principal investigators

Gretchen Kimmick,  Study Chair,  Comprehensive Cancer Center of Wake Forest University   

Study ID Numbers:  CDR0000068567; CCCWFU-74896; NCI-3137
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00015886
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08