A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer
OBJECTIVES:
- Determine the objective response rate of patients with previously untreated metastatic
gastric cancer treated with exatecan mesylate (DX-8951f).
- Determine the time to tumor progression in this patient population when treated with
this drug.
- Determine the survival at 6 and 12 months in this patient population when treated with
this drug.
- Determine the quantitative and qualitative toxic effects of this drug in this patient
population.
- Determine the pharmacokinetics of this drug in the plasma of these patients.
OUTLINE: This is a multicenter study.
Patients receive exatecan mesylate (DX-8951f) IV over 30 minutes on days 1-5. Treatment
repeats every 21 days for at least 2 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12
months.
Interventional
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Study Chair
Daiichi Sankyo Inc.
United States: Federal Government
CDR0000068663
NCT00017212
April 2001
September 2003
Name | Location |
---|---|
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |