Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction
Adenocarcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Esophagus
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (arsenic trioxide)
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.