Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine) and cisplatin. SECONDARY OBJECTIVES: 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 this regimen. 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 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Complete response rate
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Time frame: Up to 2 years
Objective response rate (CR + PR)
Will be calculated together with 95% confidence intervals based on the binomial distribution.
Time frame: Up to 2 years
Overall survival
Kaplan-Meier estimates will be determined.
Time frame: Up to 2 years
Progression-free survival
Kaplan-Meier estimates will be determined.
Time frame: From the start of treatment to progression or death, assessed up to 2 years
Duration of response
Time frame: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
Time frame: Up to 2 years
Number of patients with improvement of dysphagia
Time frame: Up to 2 years
Duration of improvement of dysphagia
Time frame: Up to 2 years
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