Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance|
- Response rate [ Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation ] [ Designated as safety issue: No ]CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
- Progression-free survival (PFS) [ Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation ] [ Designated as safety issue: No ]
- Toxicity of this drug combination [ Time Frame: Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||May 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Experimental: Celecoxib & ZD1839
Celecoxib: 400mg orally two times a day, taken with meals.
ZD1839: 250 mg po every day, taken with or without food.
Celecoxib 400mg orally two times a day, taken with meals.
Other Name: CelebrexDrug: ZD1839
ZD1839 250 mg po every day, taken with or without food.
- Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.
- 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.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Shirish M. Gadgeel, MD||Barbara Ann Karmanos Cancer Institute|