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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel; Fluorouracil

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