3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
Adenocarcinoma of the Esophagus, Recurrent Esophageal Cancer, Stage IV Esophageal Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Esophagus
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction Metastatic or recurrent disease Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Outside prior irradiation port No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 50-100% More than 6 months Absolute neutrophil count ≥ 1,500/mm^3 WBC ≥ 3,000/mm ^3 Platelet count ≥ 100,000/mm^3 AST and ALT ≤ 2.5 times upper limit of normal Bilirubin normal Creatine normal Creatinine clearance ≥ 50 mL/min No prior myocardial infarction No unstable angina No cardiac arrhythmia No uncontrolled congestive heart failure No pulmonary disease requiring supplemental oxygen Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin) No other concurrent uncontrolled illness No active or ongoing infection No active second malignancy No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents No psychiatric illness or social situation that would preclude study compliance At least 1 year since prior platinum-derivative agents No prior chemotherapy for metastatic or recurrent esophageal cancer See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered No other concurrent anticancer therapy No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (triapine and cisplatin)
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.