This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic or unresectable cancer of the esophagus or gastroesophageal junction. Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die
OBJECTIVES: I. Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide. II. Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1. Beginning on week 2, patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue to receive therapy for at least 6 months beyond CR. Patients are followed every 3 months for 6 months or until disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Given IV
M D Anderson Cancer Center
Houston, Texas, United States
Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria
Time frame: 8 weeks
Duration of response
Time frame: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 months
Toxicity graded according to the Common Toxicity Criteria version 2
Time frame: Up to 6 months
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