Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus recurrent esophageal cancer squamous cell carcinoma of the esophagus stage IV esophageal cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 58
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None

Interventions: intervention 1: ZD1839
Intervention descriptions: intervention 1: ZD1839 treatment will be taken once a day PO, every day about the same time

Protocol document: