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
- 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
- Determine the survival at 6 and 12 months in this patient population when treated with
- Determine the quantitative and qualitative toxic effects of this drug in this patient
- 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
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12
Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Daiichi Sankyo Inc.
United States: Federal Government
|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|