NCT00017212

DX-8951f in Treating Patients With Metastatic Stomach Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	exatecan mesylate

Timeline

• Start date: 2001-04-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2003-01-27
• Last updated: 2012-05-16

Locations

6 sites across 2 countries: United States, Canada