Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent|
- 1-year overall survival rate [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Time to disease recurrence [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
- 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.
- 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.
PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 9-24 months.
Show 119 Study Locations
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|
|Investigator:||George P. Kim, MD||Mayo Clinic|
|Investigator:||Jeff Sloan, PhD||Mayo Clinic|