Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene|
- Response rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Disease stabilization [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Association between clinical outcome and immunohistochemical staining [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
- Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival.
- 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.
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Julie Brahmer, MD||Sidney Kimmel Comprehensive Cancer Center|