Spots Global Cancer Trial Database for Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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Trial Identification

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

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

Study ID: NCT00293280

Conditions

Lung Cancer

Interventions

lomustine

Study Description

Brief Summary: 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: 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.