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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 is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00754923
  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 tosylate
Procedure: laboratory biomarker analysis
Procedure: mutation analysis
Procedure: polymerase chain reaction
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, 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.

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Mutational status [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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, ALK, ROS1, and K-Ras 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 and DNA 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 performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • ALT and AST ≤ 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 < 1.5 OR PT/PTT 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754923

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Clinical Trials Office - OSU Comprehensive Cancer Center     614-293-4976     osu@emergingmed.com    
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Investigators
Principal Investigator: Miguel A. Villalona-Calero, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Miguel A. Villalona-Calero )
Study ID Numbers: CDR0000614803, OSU-08017, OSU-2008C0079, BAYER-OSU-08017
Study First Received: September 17, 2008
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00754923  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma, Bronchiolo-Alveolar
Recurrence
Carcinoma
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Sorafenib
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009