Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00754923|
Recruitment Status : Terminated
First Posted : September 18, 2008
Results First Posted : June 4, 2014
Last Update Posted : March 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: sorafenib||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||October 2008|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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.
- Progression-free Survival at 6 Months [ Time Frame: 6 months ]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 Rate [ Time Frame: Up to 2 years ]Determine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC
- Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Up to 2 years ]Assess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.
- Mutational Status for EGFR or Kras [ Time Frame: up to 2 years ]
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): NCT00754923
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Principal Investigator:||Miguel A. Villalona, MD||Ohio State University|