Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine the optimal biologic dose (OBD) of celecoxib that is necessary to decrease peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells in patients with stage IIIB or IV non-small cell lung cancer. Secondary Determine the OBD of this drug that is necessary to decrease peripheral blood lymphocyte FOXP3 levels in these patients. OUTLINE: This is a nonrandomized, dose-escalation study. Patients receive oral celecoxib twice daily on days 1-7 in the absence of unacceptable toxicity. Cohorts of 3 patients receive escalating doses of celecoxib until the optimal biologic dose (OBD) is determined. The OBD is defined as the lowest dose that results in the maximum decrease in peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells and FOXP3 levels where no dose-limiting toxicity occurs. An additional 15 patients are treated at the OBD. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Official Title
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A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed non-small cell lung cancer Stage IIIB or IV disease Radiographically measurable disease 18 and over Performance status: ECOG 0-2 Renal: Creatinine ≤ 2 mg/dL Negative pregnancy test Fertile patients must use effective contraception More than 4 weeks since prior chemotherapy Endocrine therapy: More than 4 weeks since prior corticosteroids; No concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids Radiotherapy: More than 4 weeks since prior radiotherapy More than 4 weeks since other prior anticancer therapy More than 4 weeks since prior non-cytotoxic investigational agents At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs) Exclusion Criteria: pregnant or nursing comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent history of gastrointestinal ulceration, bleeding, or perforation other concurrent cyclooxygenase-2 or -3 inhibitors other concurrent NSAIDs

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: celecoxib<br> | Drug: celecoxib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OBD necessary to decrease PBL FOXP3 levels at 1 week |  | 7 dayd | 
| Function of CD4+ and CD25+ T-regulatory cells at 1 week |  | 7 days | 
| Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer