A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Metastatic Carcinoma of the Pancreas
OBJECTIVES: I. Determine the objective response rate in patients with metastatic carcinoma
of the exocrine pancreas treated with DX-8951f. II. Determine the time to tumor progression
in patients receiving this drug. III. Determine the survival at 6 and 12 months of patients
receiving this drug. IV. Evaluate the quantitative and qualitative toxicities of this
regimen in this patient population. V. Evaluate the pharmacokinetics of this drug in this
patient population.
OUTLINE: 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 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
CDR0000067147
NCT00003951
June 1999
April 2005
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |