RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.
OBJECTIVES: Primary * Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy. Secondary * Determine disease-free survival and time to disease recurrence in patients treated with this drug. * Determine the toxicity of this drug in these patients. * Determine the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. Patients are followed every 3 months for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
1-year overall survival rate
Time frame: Up to 12 months
Survival time
Time frame: Up to 5 years
Disease-free survival
Time frame: Up to 5 years
Time to disease recurrence
Time frame: Up to 5 years
Time to treatment failure
Time frame: Up to 5 years
Quality of life
Time frame: Up to 5 years
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