This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride). II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug. IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients. OUTLINE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Given PO
Correlative studies
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Major response rate (complete and partial response)
Time frame: Up to 5 years
Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
Time frame: Up to 5 years
Degree of dysphagia relief
Time frame: Up to 5 years
Time to progression
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.
Time frame: Up to 5 years
Overall survival
Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.
Time frame: Up to 5 years
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