Esophageal Cancer Clinical Trial
Official title:
A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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