Gastric Cancer Clinical Trial
Official title:
A Phase II Study of CPT-11 and 5-FU/LCV in Patients With Previously Untreated Gastric Adenocarcinoma
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.
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
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