Phase I/II Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer
OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients
with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the
qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these
patients. III. Determine the clinical pharmacology of this regimen in these patients. IV.
Determine the rationale for the dose and chosen schedule of this regimen in these patients.
OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment
continues every 3 weeks for at least 2 courses in the absence of disease progression or
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30
Primary Purpose: Treatment
Matthew D. Volm, MD
New York University School of Medicine
United States: Federal Government
|NYU School of Medicine's Kaplan Comprehensive Cancer Center||New York, New York 10016|