Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.|
- Progression-free Survival at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate
- Overall Survival [ Time Frame: 2008-present ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2008-present ] [ Designated as safety issue: Yes ]
- Mutational Status for EGFR or Kras [ Time Frame: 2008-present ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Treatment: Sorafenib
Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
- To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free survival rate, in non-smokers or former light smokers with relapsed or refractory stage IIIB or IV non-small cell lung cancer.
- To determine the 1-year survival rate in patients treated with this drug.
- To assess the frequency and severity of adverse events associated with this drug in these patients.
- To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene homolog)in archived tumor samples from these patients.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing.
After completion of study treatment, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754923
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Principal Investigator:||Miguel A. Villalona, MD||Ohio State University|