NCT00100945

Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer

A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · 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 locally advanced esophageal cancer.

Detailed description

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	gefitinib

Timeline

• Start date: 2005-07-01
• Primary completion: 2007-08-01
• Completion: 2009-10-01
• First posted: 2005-01-10
• Last updated: 2016-12-13

Locations

119 sites across 1 country: United States