DX-8951f in Treating Patients With Metastatic Stomach Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have metastatic stomach cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||April 2001|
|Study Completion Date:||September 2003|
|Primary Completion Date:||September 2003 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|Pacific Shores Medical Group|
|Long Beach, California, United States, 90813|
|United States, Colorado|
|Rocky Mountain Cancer Centers|
|Denver, Colorado, United States, 80218|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Cancer Therapy and Research Center|
|San Antonio, Texas, United States, 78229-3264|
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo Inc.|