A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer
- Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated
doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy.
- Determine the pharmacokinetics of intraductal pegylated doxorubicin HCl liposome,
including serial plasma concentrations of doxorubicin and doxorubicinol and tissue
concentrations in different portions of the breast at the time of surgery.
OUTLINE: This is a dose-escalation study.
Patients receive an intraductal injection of pegylated doxorubicin HCl liposome* on day 1.
Patients undergo mastectomy 2-4 weeks later.
Cohorts of 3-6 patients receive escalating doses of pegylated doxorubicin HCl liposome*
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At
least 6 patients are treated at the MTD.
NOTE: *The first cohort of 3 patients receive intraductal dextrose only followed by surgery
as a feasibility study.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility and safety after definitive surgery
After definitive surgery
Vered Stearns, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Indiana University Melvin and Bren Simon Cancer Center||Indianapolis, Indiana 46202-5289|