A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma
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.
Primary Purpose: Treatment
Al B. Benson, MD, FACP
Robert H. Lurie Cancer Center
United States: Federal Government
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Vanderbilt Cancer Center||Nashville, Tennessee 37232-6838|