Docetaxel in Treating Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2007-01-01
• 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.

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast cancer

• Bidimensionally measurable disease

• No uncontrolled brain metastases or leptomeningeal disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count at least 100,000/mm^3

• Neutrophil count at least 1,000/mm^3

• Hemoglobin at least 8 g/dL

Hepatic:

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN)

• Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN)

Renal:

• Creatinine no greater than 2.0 mg/dL

Neurologic:

• No peripheral neuropathy grade 2 or greater

• Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis

• No psychiatric disorders

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy

• No other serious condition or illness, including active infection

• No history of hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Recovered from prior chemotherapy

• No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease)

• No prior paclitaxel or docetaxel (except in the adjuvant setting)

• At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel)

• Prior anthracycline-based therapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 2 weeks since prior radiotherapy and recovered

Surgery:

• At least 2 weeks since prior surgery and recovered