Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
- Registration Number
- NCT00100945
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gefitinib 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.
- Primary Outcome Measures
Name Time Method 1-year overall survival rate Up to 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (119)
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Scroll for more (109 remaining)Mobile Infirmary Medical Center🇺🇸Mobile, Alabama, United States