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

This study has been terminated.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Miguel Villalona, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00754923
First received: September 17, 2008
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Lung Cancer
Drug: sorafenib
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: October 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment: Sorafenib
Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
Drug: sorafenib
administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Other Names:
  • Nexavar
  • sorafenib tosylate

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer

    • Stage IIIB or IV disease
    • Recurrent disease after prior surgery, chemotherapy, or radiotherapy
    • No squamous cell histology or mixed tumor with > 50% squamous cells
  • Non-smoker (smoked ≤ 100 cigarettes in lifetime) OR former light smoker (smoked > 100 cigarettes but ≤ 10 pack years AND quit smoking ≥ 1 year ago)
  • No known brain metastasis

    • Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis

PATIENT CHARACTERISTICS:

  • ECOG(Eastern Cooperative Oncology Group)performance status 0-2
  • ANC (Absolute Neutrophil Count)≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • ALT (Alanine Aminotransferase Test) and AST (Aspartate Aminotransferase Test) ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min
  • INR (International Normalized Ratio) < 1.5 OR PT/PTT (Prothrombin time/partial thromboplastin time)normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception prior to, during, and for ≥ 3 months after completion of study treatment
  • No cardiac disease, including any of the following:

    • New York Heart Association class III-IV congestive heart failure
    • Unstable angina (anginal symptoms at rest)
    • New-onset angina within the past 3 months
    • Myocardial infarction within the past 6 months
  • No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 90 mm Hg) despite optimal medical management
  • No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
  • No pulmonary hemorrhage or bleeding event ≥ CTCAE (Common Terminology Criteria for Adverse Events)grade 2 within the past 4 weeks
  • No other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks
  • No active clinically serious infection > CTCAE grade 2
  • No serious non-healing wound, ulcer, or bone fracture
  • No evidence or history of bleeding diathesis or coagulopathy
  • No known HIV infection or chronic hepatitis B or C
  • No other malignancy except for any of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Other cancer from which the patient has been disease-free for ≥ 5 years with a low probability of recurrence
  • No condition that impairs the patient's ability to swallow whole pills
  • No malabsorption problems
  • No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study
  • No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than one prior systemic chemotherapy treatment for metastatic disease

    • Prior treatment with EGFR inhibitors is not considered chemotherapy
  • More than 4 weeks since prior major surgery or open biopsy
  • No prior sorafenib tosylate
  • No concurrent St. John's wort or rifampin
  • Concurrent anticoagulation with warfarin or heparin allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754923

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Bayer
Investigators
Principal Investigator: Miguel A. Villalona, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Miguel Villalona, Prinicipal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00754923     History of Changes
Other Study ID Numbers: OSU-08017, NCI-2011-03192
Study First Received: September 17, 2008
Results First Received: April 15, 2014
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014