DX-8951f in Treating Patients With Metastatic Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00017212|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Gastric Cancer||Drug: exatecan mesylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||September 2003|
|Actual Study Completion Date :||September 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017212
|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.|