Celecoxib and Erlotinib 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 cancer by stopping blood flow to the tumor. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining celecoxib with erlotinib may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer. Determine the toxicity profile of this regimen in these patients. Secondary Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients. Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen. OUTLINE: This is a nonrandomized, dose-escalation study of celecoxib. Patients receive oral erlotinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment beyond 2 courses at the investigator's discretion. Cohorts of 3-6 patients receive escalating doses of celecoxib until the maximum tolerated dose (MTD) and biologically active dose (BAD) are determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT). The BAD is defined as the maximum decrease in the level of PGE_2 where no DLT occurs. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 21-27 patients will be accrued for this study.

Official Title
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A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: celecoxib
* Drug: erlotinib hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB or IV Measurable disease Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy No active CNS metastases PATIENT CHARACTERISTICS: Age 21 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal (ULN) PT and/or PTT no greater than 1.5 times ULN Renal Creatinine no greater than 2 mg/dL Cardiovascular No New York Heart Association class III or IV cardiac disease No myocardial infarction within the past year No symptomatic ventricular arrhythmia No symptomatic conduction abnormality Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior gastrointestinal ulceration, bleeding, or perforation No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study No concurrent disease or medical condition that would preclude study treatment or compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy Endocrine therapy More than 4 weeks since prior corticosteroids No concurrent steroids (including chronic use) Concurrent topical steroids allowed Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 4 weeks since prior non-cytotoxic investigational agents More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs) No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC No prior epidermal growth factor receptor inhibitor for metastatic NSCLC No concurrent COX-2 inhibitors No concurrent NSAIDs No concurrent fluconazole or lithium

Ages Eligible for Study
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Minimum Age: 21 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: erlotinib hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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