Spots Global Cancer Trial Database for DX-8951f in Treating Patients With Metastatic Stomach Cancer

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Trial Identification

Brief Title: DX-8951f in Treating Patients With Metastatic Stomach Cancer

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 ID: NCT00017212

Conditions

Esophageal Cancer

Gastric Cancer

Interventions

exatecan mesylate

Study Description

Brief Summary: 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.

Detailed Description: 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.