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Clinical Trial 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).


Clinical Trial 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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00068653
Study type Interventional
Source Barbara Ann Karmanos Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date June 2003
Completion date May 2008

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