Lomustine in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00293280|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : May 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: lomustine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Masking:||None (Open Label)|
|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 Start Date :||July 2005|
|Actual Primary Completion Date :||July 2007|
- Response rate
- Disease stabilization
- Time to disease progression
- Overall survival
- Association between clinical outcome and immunohistochemical staining
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293280
|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 at Johns Hopkins|