NCT00100945CompletedPhase 2
A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
Alliance for Clinical Trials in Oncology119 sites in 1 country70 target enrollmentStarted: July 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 70
- Locations
- 119
- Primary Endpoint
- 1-year overall survival rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
gefitinib
Experimental
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 (Drug)
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)
Investigators
Study Sites (119)
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