A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
I. Determine the objective response rate in patients with recurrent or metastatic
adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine)
I. Determine the toxicity of this regimen in these patients. II. Determine the duration of
response and overall survival of patients treated with this regimen.
III. Determine the palliative benefits with regard to dysphagia in patients treated with
OUTLINE: This is a multicenter study.
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive
cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every
21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Up to 2 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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