A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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