Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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Concurrent chemoradiation (ChRT) is a standard care for unresectable stage III non-small cell lung cancer (NSCLC) patients with good performance status, and cisplatin/etoposide (EP) regimen is one of the most commonly used regimens. However, the prognosis of these patients is still rather poor. It has been demonstrated that Cyclooxygenase (COX)-2 plays an important role in the pathogenesis of lung cancer. Selective (COX)-2 inhibitors can promote chemosensitivity and radiosensitivity of tumor cells in preclinical trials. This is a single-institution, open-label, randomized phase II trial of celecoxib administered concurrently with cisplatin, etoposide, and radiation therapy in patients with locally advanced NSCLC, to determine the feasibility, activity, and toxicity of this combination on unresectable NSCLC, and further to examine biomarkers to predict response to the treatment.

Detailed Description
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Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS) Recent studies have shown that celecoxib has antitumor activity, and may increase the tumor sensitivity to radiation. Furthermore, evidence has shown the safety and efficiency of celecoxib in some phase I/II studies. The purposes of this study are to examine the effects of a new combination of celecoxib (Celebrex®) and cisplatin/etoposide (EP regimen), with concurrent thoracic radiotherapy on unresectable stage III NSCLC patients; and to examine biomarkers to predict response to the treatment. Because of poor survival of patients with unresected locally advanced NSCLC, the efficiency of celecoxib plus concurrent EP chemoradiotherapy need to be further investigated.

Official Title
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A Randomized Phase II Trial of Cisplatin/Etoposide and Concurrent Radiotherapy With or Without Celecoxib in Patients With Unresectable Locally Advanced Non-small Cell Lung Cancer

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: • 18-70 years old, male or female Histological or cytological evidence of NSCLC. Unresectable Stage III NSCLC. Karnofsky score: at least 70. Estimated survival: at least 6 months Not receiving radiotherapy or combined modality therapy to treat another malignancy. No history of active gastric ulcer, active GI bleeding, or renal failure. No severe hypertension, cardiac disease, or diabetes mellitus Normal blood routine and chemical tests Patients or guardian must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: • Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer Extensive distant metastases Pregnancy or in lactation Allergic to Sulfonamides, NSAIDS or Celebrex Routine use of NSAIDS such as high dose of Aspirin History of cardiovascular diseases including: myocardial infraction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery in the last 6 months. Abnormal coagulation or history of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous, family history of protein S or C deficiencies, prior heparin-induced thrombocytopenia, Factor V Leiden deficiencies or high homocysteine levels.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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>Combination of and concurrent radiotherapy Cisplatin/etoposide with or without Celecoxib. Intervention: Drug: Celecoxib | Drug: Celecoxib<br>* 400 mg by mouth twice daily for for 5-7 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 6 weeks).<br>* Other names: Celebrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 year overall survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 3 year progression-free survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celecoxib, phase II