OBJECTIVES:

• Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide.
• Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1. Beginning on week 2, patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue to receive therapy for at least 6 months beyond CR.

Patients are followed every 3 months for 6 months or until disease progression.

PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction

  • Metastatic or unresectable local-regional disease
  • Osseous metastasis as the only site of disease not eligible

• Measurable disease

  • Mediastinal or hilar lymph nodes must be at least 2.0 cm in diameter by CT scan or MRI to be considered measurable
• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-2 OR
• Karnofsky 60-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT and/or SGPT no greater than 2.0 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 1.5 times ULN
• Creatinine clearance at least 60 mL/min
• Calcium no greater than 12 mg/dL
• No symptomatic hypercalcemia under treatment

Cardiovascular

• No New York Heart Association class III or IV heart disease
• No angina within the past 6 months
• No myocardial infarction within the past 6 months
• No congestive heart failure within the past 6 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

• No other concurrent active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix

  • Prior malignancies with no evidence of disease for at least 2 years are allowed
• No serious concurrent infection that is uncontrolled or whose control could be jeopardized by complications of study therapy
• No concurrent nonmalignant medical illness that is uncontrolled or whose control could be jeopardized by complications of study therapy
• No psychiatric disorder or other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior immunotherapy (including adjuvant or preoperative regimens)
• No concurrent biological response modifiers
• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• No prior chemotherapy (including adjuvant or preoperative regimens and radiosensitizers)

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy and recovered
• No prior radiotherapy to major bone marrow containing areas (e.g., pelvis or lumbar spine) or area that contained the indicator lesion
• No prior radiotherapy involving 30% or more of the bone marrow
• No concurrent radiotherapy

Surgery

• At least 2 weeks since prior major surgery (4 days for minor surgery) and recovered

Other

• No other concurrent investigational drugs
• No other concurrent antineoplastic therapy