Phase II Study of TLC D-99 for Hepatobiliary Carcinomas
OBJECTIVES: I. Determine the response rate and toxicity of doxorubicin HCl liposome in
patients with carcinomas of the liver and bile ducts.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 15 minutes every 21 days.
Filgrastim (G-CSF) is administered subcutaneously starting on day 2 and continuing for 10-14
days. Disease is restaged after every 3 courses. Treatment continues in the absence of
unacceptable toxicity or disease progression. Patients are followed every 3 months for the
first year, and then every 6 months thereafter.
PROJECTED ACCRUAL: There will be 17-26 evaluable patients accrued into this study.
Primary Purpose: Treatment
Howard Safran, MD
United States: Federal Government
|New England Medical Center Hospital||Boston, Massachusetts 02111|
|Brown University Oncology Group||Providence, Rhode Island 02912|