A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
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
Secondary
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.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
Locally advanced disease
T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement
Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months
No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No prior gefitinib
No concurrent CYP3A4 inducing agents, including any of the following:
No concurrent antacids 4 hours before or after study drug administration
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