A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Hormone-Refractory Prostate Cancer
OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in
patients with hormone refractory prostate cancer. II. Determine the antitumor activity of
this drug in the subpopulation of these patients with measurable disease. III. Evaluate the
quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the
pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for
5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable
toxicity or disease progression. Patients with no evidence of PSA decrease by the start of
course 3 receive no further treatment. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Study Chair
Daiichi Sankyo Inc.
United States: Federal Government
CDR0000067146
NCT00004045
June 1999
August 2001
Name | Location |
---|---|
U.S. Oncology Research Inc. | Houston, Texas 77060 |
Institute for Drug Development | San Antonio, Texas 78245-3217 |