Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations. Secondary To determine the complete resection rate in patients treated with this drug. To determine the overall survival rate in patients treated with this drug. To determine the disease-free survival rate in patients treated with this drug. To determine the pathologic complete response rate in patients treated with this drug. To determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy. After completion of study therapy, patients are followed for 2 years.

Official Title
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A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: gefitinib
* Procedure: neoadjuvant therapy
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer pN2 disease proven by mediastinoscopy Meets any of the following criteria: Never smoked EGFR mutations (in exon 18, 19, or 21)* FISH positive for EGFR* NOTE: *Irrespective of smoking history Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST Feasible to undergo pneumonectomy or lobectomy PATIENT CHARACTERISTICS: Inclusion criteria: ECOG performance status 0-1 FEV_1 ≥ 2.0 L in preoperative pulmonary function test Hemoglobin ≥ 9.0 g/dL WBC 4,000-12,000/μL ANC ≥ 1,500/μL Platelet count ≥ 100,000/mm³ Total bilirubin ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 3.0 times ULN AST and ALT ≤ 3.0 times ULN Creatinine ≤ 1.5 times ULN Negative pregnancy test Exclusion criteria: Severe complications or infections Pregnant or breast-feeding women Clinically significant heart disease Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma PRIOR CONCURRENT THERAPY: No prior radiotherapy, chemotherapy, hormone therapy, or target therapy No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gefitinib|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete resection rate |  |  | 
| Overall survival rate |  |  | 
| Median disease-free survival |  |  | 
| Complete pathological response rate |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA non-small cell lung cancer, adenocarcinoma of the lung, bronchoalveolar cell lung cancer, large cell lung cancer