A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma

Date de début de l'étude : 1 janvier 2004

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