A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
Overview
- Phase
- Phase 2
- Intervention
- gefitinib
- Conditions
- Esophageal Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 70
- Locations
- 119
- Primary Endpoint
- 1-year overall survival rate
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
gefitinib
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.
Intervention: gefitinib
Outcomes
Primary Outcomes
1-year overall survival rate
Time Frame: Up to 12 months
Secondary Outcomes
- Time to treatment failure(Up to 5 years)
- Disease-free survival(Up to 5 years)
- Survival time(Up to 5 years)
- Quality of life(Up to 5 years)
- Time to disease recurrence(Up to 5 years)