Lung Cancer Clinical Trial
Official title:
Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary
for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the
tumor. Combining gefitinib with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in
treating patients who have non-small cell lung cancer that is refractory to platinum-based
chemotherapy (such as cisplatin or carboplatin).
OBJECTIVES:
Primary
- Determine the response rate in patients with platinum-refractory non-small cell lung
cancer treated with gefitinib and celecoxib.
Secondary
- Determine the progression-free and overall survival of patients treated with this
regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days
1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed for up to 6 weeks.
PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22
months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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