Esophageal Cancer Clinical Trial
Official title:
A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction
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
recurrent or metastatic esophageal or gastroesophageal junction cancer.
OBJECTIVES:
Primary
- Explore the activity of single agent gefitinib, in terms of response rate, in a patient
population with recurrent or metastatic esophageal or gastroesophageal junction cancer.
Secondary
- Assess the toxicity of this drug in these patients.
OUTLINE: Patients are stratified according to prior treatment (yes vs no).
Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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