DX-8951f in Treating Patients With Metastatic Stomach Cancer
- Conditions
- Gastric CancerEsophageal 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, 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
Pacific Shores Medical Group🇺🇸Long Beach, California, United States