Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Cancer of the Stomach or Esophagus
- Conditions
- Esophageal CancerGastric Cancer
- Registration Number
- NCT00005607
- Lead Sponsor
- Robert H. Lurie Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the stomach or esophagus.
- Detailed Description
OBJECTIVES: I. Determine the response rate of patients with metastatic or recurrent adenocarcinoma of the stomach or gastroesophageal junction when treated with irinotecan, fluorouracil, and leucovorin calcium. II. Determine the qualitative and quantitative toxicity, and reversibility of toxicity, of this regimen in this patient population.
OUTLINE: Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV over 15 minutes, and fluorouracil IV once weekly for 4 weeks followed by 2 weeks of rest. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed at 30 days, and then until death.
PROJECTED ACCRUAL: A total of 18-37 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- 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 (4)
Vanderbilt Cancer Center
🇺🇸Nashville, Tennessee, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
🇺🇸Chicago, Illinois, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States