DX-8951f in Treating Patients With Metastatic Stomach Cancer

Phase 2

Completed

• Conditions: Gastric Cancer; Esophageal Cancer

• Registration Number: NCT00017212
• Lead Sponsor: Daiichi Sankyo

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-06-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

Simmons Cancer Center - Dallas; 🇺🇸 Dallas, Texas, United States

Pacific Shores Medical Group; 🇺🇸 Long Beach, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States

Cancer Care Ontario-Hamilton Regional Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada