RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.

Condition	Treatment or Intervention	Phase
recurrent esophageal cancer stage IV esophageal cancer Adenocarcinoma of the Esophagus	Drug: 3-AP  Drug: cisplatin  Procedure: chemosensitization/potentiation  Procedure: chemotherapy	Phase II

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
      Central Illinois Hematology Oncology Center, Springfield,  Illinois,  62701,  United States; Recruiting
      Decatur Memorial Hospital Cancer Care Institute, Decatur,  Illinois,  62526,  United States; Recruiting
      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201-1781,  United States; Recruiting
      Ingalls Memorial Hospital, Harvey,  Illinois,  60426,  United States; Recruiting
      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61602,  United States; Recruiting
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States; Recruiting
Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States; Recruiting
      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States; Recruiting
Michigan
      Oncology Care Associates, P.L.L.C., Saint Joseph,  Michigan,  49085,  United States; Recruiting
Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226,  United States; Recruiting

Study chairs or principal investigators

Ann M. Mauer, MD,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000352307; UCCRC-12765A; NCI-6285
Record last reviewed:  August 2004
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077545
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-22