Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Compare the time to progression in patients with stage II-IIIB non-small cell lung cancer treated with celecoxib vs observation after treatment with chemoradiotherapy. Secondary Compare the 2-year survival rate of patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare weight changes and objective response in patients treated with these regimens. Compare tolerability of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and total dose of radiotherapy (65 Gy vs 60 Gy). All patients undergo radiotherapy 5 days a week for 7.5 weeks. Patients also receive docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Three weeks after the completion of radiotherapy, patients receive docetaxel alone IV over 30 minutes on days 1 and 22. Three weeks later, patients are randomized to 1 of 2 treatment arms. Arm I: Patients are observed every 3 months for 1 year and then every 6 months for 1 year. Arm II: Patients receive oral celecoxib twice daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Official Title
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Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: celecoxib
* Drug: docetaxel
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer meeting ≥ 1 of the following criteria: Stage IIIB disease Stage II or IIIA disease, meeting the following criteria: Considered nonresectable Pleural effusion present Measurable disease Must have received a prior regimen of radiotherapy and chemotherapy comprising docetaxel and carboplatin Tumor volume must be able to be encompassed in the radiation field PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 12 weeks Cardiac function compatible with radiotherapy Neutrophil count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.25 times ULN AST and ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Not pregnant or nursing No other malignancy in the past 10 years except basal cell skin cancer or carcinoma in situ of the cervix No active infection No inflammatory bowel disease No severe congestive heart failure No severe hepatic disease defined as albumin < 25 g/L or Child-Pugh score ≥ 10 No severe renal disease defined as creatinine clearance < 30 mL/min No known hypersensitivity to sulfonamides, the study or it's excipients, or polysorbate 80 No known hypersensitivity of NSAIDs, salicylic acid, or cyclo-oxygenase-2 inhibitors No familial, social, geographical, or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 30 days since participation in another clinical study More than 1 month since prior therapy for gastrointestinal ulcers No concurrent fluconazole, ketoconazole, lithium, or dextromethorphan No other concurrent anticancer treatment including chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic response modifier therapy No concurrent aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) Low-dose aspirin or NSAIDs for a duration of ≤ 1 week during the past 3 months allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Drug: docetaxel|nan|
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year survival rate |  |  | 
| Quality of life |  |  | 
| Weight changes |  |  | 
| Objective response |  |  | 
| Tolerability |  |  | 

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