NCT00068653

Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer

Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Celecoxib	Celecoxib 400mg orally two times a day, taken with meals.
DRUG	ZD1839	ZD1839 250 mg po every day, taken with or without food.

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-10-01
• Completion: 2008-05-01
• First posted: 2003-09-11
• Last updated: 2013-04-29

Locations

1 site across 1 country: United States