A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hepatocellular Carcinoma
OBJECTIVES: I. Evaluate the antitumor activity of DX-8951f in terms of antitumor response,
response duration, and survival in patients with hepatocellular carcinoma. II. Assess the
quantitative and qualitative toxicities of this treatment regimen in this patient
population. III. Evaluate the pharmacokinetics of DX-8951 in plasma.
OUTLINE: Patients receive DX-8951f IV over 30 minutes daily for 5 days. Treatment repeats
every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 12 months.
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Daiichi Sankyo Inc.
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Colorado Cancer Center||Denver, Colorado 80262|
|Cancer Therapy & Research Center||San Antonio, Texas 78229|