NCT00268346

Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer

A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	ZD1839	ZD1839 treatment will be taken once a day PO, every day about the same time

Timeline

• Start date: 2005-10-01
• Primary completion: 2011-01-01
• Completion: 2011-08-01
• First posted: 2005-12-22
• Last updated: 2016-01-05
• Results posted: 2012-03-16

Locations

1 site across 1 country: United States