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Brief Title: 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Official Title: A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
Study ID: NCT00077545
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Name: Ann Mauer
Affiliation: University of Chicago Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR