Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
Overview
- Phase
- Phase 2
- Intervention
- Celecoxib
- Conditions
- Lung Cancer
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Response rate
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Celecoxib & ZD1839
Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food.
Intervention: Celecoxib
Celecoxib & ZD1839
Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food.
Intervention: ZD1839
Outcomes
Primary Outcomes
Response rate
Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
Secondary Outcomes
- Progression-free survival (PFS)(Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation)
- Overall survival(Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation)
- Toxicity of this drug combination(Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity)