Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
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|ClinicalTrials.gov Identifier: NCT00061958|
Recruitment Status : Terminated (Administratively complete.)
First Posted : June 6, 2003
Last Update Posted : January 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Esophagus Stage III Esophageal Cancer Stage IV Esophageal Cancer||Drug: arsenic trioxide||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||April 2005|
Experimental: Treatment (arsenic trioxide)
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 CR continue to receive therapy for at least 6 months beyond CR.
Drug: arsenic trioxide
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061958
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jaffer Ajani||M.D. Anderson Cancer Center|