Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well lomustine works in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene. Determine whether the response rate in these patients is significantly greater than that of the historical control. Secondary Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival. Tertiary Evaluate the association between clinical outcome and immunohistochemical staining by grouping the patients as complete or partial loss of MGMT gene. OUTLINE: This is a multicenter study. Patients receive oral lomustine once on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Official Title
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Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: lomustine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes: Squamous cell Adenocarcinoma Adenosquamous Large cell anaplastic Bronchoalveolar Non-small cell carcinoma not otherwise specified (NOS) Stage IIIB disease (with a pleural effusion) or stage IV disease Stage IV patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction Bidimensionally measurable or evaluable disease PATIENT CHARACTERISTICS: ECOG performance status 0-2 No other active malignancies WBC ≥ 4,000/mm^3 OR absolute neutrophil count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Total bilirubin normal AST < 5 times upper limit of normal Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min No uncontrolled serious active infection Not pregnant or nursing PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 3 weeks since prior chemotherapy No more than 2 prior chemotherapy regimens No prior therapy with nitrosoureas Recovered from prior radiation therapy

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: lomustine|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 |
| --- | --- | --- |
| Toxicity |  |  | 
| Disease stabilization |  |  | 
| Time to disease progression |  |  | 
| Overall survival |  |  | 
| Association between clinical outcome and immunohistochemical staining |  |  | 

 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, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer