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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00754923 |
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 |
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Lung Cancer |
Drug: sorafenib tosylate Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: polymerase chain reaction |
Phase II |
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. |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
No known brain metastasis
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
No other malignancy except for any of the following:
PRIOR CONCURRENT THERAPY:
No more than one prior systemic chemotherapy treatment for metastatic disease
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 |
Principal Investigator: | Miguel A. Villalona-Calero, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
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 |
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 |
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 |
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 |