Stage IV Esophageal Cancer Clinical Trial
Official title:
A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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