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

Stopped early · Phase 2

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

In brief

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

Key facts

Study ID

NCT00061958

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2003-06-01

Last updated by the study team

2013-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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