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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Response rate
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
Time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Progression-free survival (PFS)
Time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Overall survival
Time frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
Toxicity of this drug combination
Time frame: Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity
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