Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Lung Cancer
• Interventions: Drug: sorafenib

• Registration Number: NCT00754923
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Study Start: 2008-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2014-04-15
• Results First Submitted QC: 2014-05-14
• Results First Posted: 2014-06-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment: Sorafenib	sorafenib	Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival at 6 Months	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

Secondary Outcome Measures

Name	Time	Method
Mutational Status for EGFR or Kras	up to 2 years
Overall Survival Rate	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)	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.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States