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

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: fluorouracil; Drug: docetaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00015886

CDR0000068567

NCI-3137

CCCWFU-74896

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)