High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer
OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide,
paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV
advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered
with amifostine in this regimen in these patients. III. Assess the toxicity of this
treatment regimen in this patient population.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for
peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC
collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a
continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on
day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day
-2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF
subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years,
then periodically thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.
Primary Purpose: Treatment
George Somlo, MD
Beckman Research Institute
United States: Federal Government
|Cancer Center and Beckman Research Institute, City of Hope||Duarte, California 91010-3000|