Trial Information

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

OBJECTIVES: I. Estimate the maximum tolerated dose of paclitaxel when given with high-dose
carboplatin/cyclophosphamide with autologous peripheral blood stem cell support in women
with high-risk stage II/III breast cancer. II. Assess the nonhematologic toxicities
associated with this combination. III. Assess the progression-free and overall survival of
these patients following this treatment.

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 6-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days,
then carboplatin for 3 days. Four 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, then every 4-6 months
thereafter.

PROJECTED ACCRUAL: It is expected that 24-30 patients will be accrued; a study duration of
1-1.5 years is anticipated.