Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction

Study Overview
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Brief Summary
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This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic or unresectable cancer of the esophagus or gastroesophageal junction. Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description
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OBJECTIVES: I. Determine the response rate and duration of response in patients with advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with arsenic trioxide. II. 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.

Official Title
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A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction

Conditions
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Adenocarcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Performance status - Zubrod 0-2 Performance status - Karnofsky 60-100% At least 12 weeks Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Bilirubin no greater than 1.5 mg/dL SGOT and/or SGPT no greater than 2.0 times upper limit of normal (ULN) 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 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 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 No prior immunotherapy (including adjuvant or preoperative regimens) No concurrent biological response modifiers No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) No prior chemotherapy (including adjuvant or preoperative regimens and radiosensitizers) 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 At least 2 weeks since prior major surgery (4 days for minor surgery) and recovered No other concurrent investigational drugs No other concurrent antineoplastic therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (arsenic trioxide)<br>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 CR continue to receive therapy for at least 6 months beyond CR. | Drug: arsenic trioxide<br>* Given IV<br>* Other names: Trisenox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response |  | From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 months | 
| Toxicity graded according to the Common Toxicity Criteria version 2 |  | Up to 6 months |