Gastric Cancer Clinical Trial
Official title:
A Phase II Study of Oxaliplatin in Combination With Fluorouracil and Leucovorin in Carcinoma of the Esophagus and Gastric Cardia
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 combining oxaliplatin with
fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of
the esophagus or stomach.
OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic
carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin,
fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall
survival of this patient population receiving this regimen. III. Determine the toxicity,
including neurotoxicity, of this regimen in this patient population.
OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2
hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed
by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a
minimum of 3 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease receive at least 3 additional courses of therapy.
Patients are followed for a minimum of 2 years or until death.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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