• Objective response rate (complete and partial) [ Designated as safety issue: No ]
  

• Duration of response [ Designated as safety issue: No ]
  
• Progression-free survival [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  
• Improvement in dysphagia [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• 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

• Determine the toxicity of this regimen in these patients.
• Determine the duration of response and overall survival of patients treated with this regimen.
• 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.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR
• Karnofsky 50-100%

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• WBC ≥ 3,000/mm ^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal
• Bilirubin normal

Renal

• Creatine normal OR
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No prior myocardial infarction
• No unstable angina
• No cardiac arrhythmia
• No uncontrolled congestive heart failure

Pulmonary

• No pulmonary disease requiring supplemental oxygen

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 1 year since prior platinum-derivative agents
• No prior chemotherapy for metastatic or recurrent esophageal cancer

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• At least 2 weeks since prior radiotherapy and recovered

Surgery

• Not specified

Other

• No other concurrent anticancer therapy
• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients