PHASE I/II TRIAL OF THE ADDITION OF TAXOL TO THE HIGH DOSE CARBOPLATIN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN PATIENTS WITH BREAST CANCER

OBJECTIVES: I. Estimate the maximum tolerated dose of paclitaxel in combination with high-dose carboplatin/cyclophosphamide followed by autologous peripheral blood stem cell support in women with stage IV breast cancer. II. Assess the nonhematologic toxic effects associated with this combination. III. Assess the response rate, duration of response, and survival in chemotherapy-sensitive women with metastatic breast cancer treated with this regimen.

OUTLINE: This is a dose-finding study. All patients undergo collection of peripheral blood stem cells (PBSC) with granulocyte colony-stimulating factor (G-CSF) mobilization prior to high-dose chemotherapy. Cohorts of 3-5 patients are treated at successively higher dose levels of paclitaxel until a maximum tolerated dose (MTD) is found. Paclitaxel is given as a single 24-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days, then carboplatin for 4 days. Three days later, patients receive PBSC and G-CSF for hematopoietic reconstitution. Additional patients are entered at the MTD. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and every 4-6 months thereafter.

PROJECTED ACCRUAL: 50 patients will be accrued. The study is expected to take 18 months.