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Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction

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

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00061958
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Terminated
Phase Phase 2
Start date June 2003
View Details
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