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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bayer |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00600015 |
This trial will investigate the use of the newer targeted agents erlotinib and sorafenib in patients with stage IIIB or stage IV NSCLC who have received 1-2 prior chemotherapy regimens. Patients will be randomized to receive erlotinib (150 mg/day) and sorafenib (400 mg twice daily), or erlotinib (150 mg/day) and a placebo.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Erlotinib + Sorafenib Drug: Erlotinib + Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Double-Blind Placebo-Controlled Phase II Trial of Sorafenib and Erlotinib or Erlotinib Alone in Previously Treated Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 168 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Erlotinib + Sorafenib
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Drug: Erlotinib + Sorafenib
Patients who are randomized to Cohort A will take sorafenib 400 mg (2 x 200-mg tablets) orally twice a day, and erlotinib 150 mg orally once a day.
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B: Experimental
Erlotinib + Placebo
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Drug: Erlotinib + Placebo
Patients who are randomized to Cohort B will take erlotinib 150 mg orally once a day and placebo orally twice a day.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Significant cardiac disease within 90 days of starting study treatment, including:
United States, Florida | |
Florida Cancer Specialists | |
Fort Myers, Florida, United States, 33901 | |
United States, Georgia | |
Northeast Georgia Medical Center | |
Gainesville, Georgia, United States, 30501 | |
Wellstar Cancer Research | |
Marietta, Georgia, United States, 30060 | |
United States, Kansas | |
Kansas City Cancer Centers | |
Overland Park, Kansas, United States, 66210 | |
United States, Maryland | |
Center for Cancer and Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
United States, Michigan | |
Grand Rapids Clinical Oncology Program | |
Grand Rapids, Michigan, United States, 49503 | |
United States, Nebraska | |
Methodist Cancer Center | |
Omaha, Nebraska, United States, 68114 | |
United States, North Carolina | |
Cancer Care of Western North Carolina | |
Asheville, North Carolina, United States, 28801 | |
United States, Ohio | |
Oncology Hematology Care | |
Cincinnati, Ohio, United States, 45242 | |
Mid Ohio Oncology/Hematology, Inc./ The Mark H. Zangmeister Center | |
Columbus, Ohio, United States, 43219 | |
United States, South Carolina | |
South Carolina Oncology Associates, PA | |
Columbia, South Carolina, United States, 29210 | |
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 | |
Chattanooga Oncology Hematology Associates | |
Chattanooga, Tennessee, United States, 37404 | |
Family Cancer Center | |
Collierville, Tennessee, United States, 38017 | |
United States, Texas | |
Coastal Bend Cancer Center | |
Corpus Christi, Texas, United States, 78463 | |
United States, Virginia | |
Virginia Cancer Institute | |
Richmond, Virginia, United States, 23235 |
Study Chair: | David Spigel, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | SCRI Oncology Research Consortium ( David Spigel, M.D. ) |
Study ID Numbers: | SCRI LUN 160, SR06-1015 |
Study First Received: | December 26, 2007 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00600015 History of Changes |
Health Authority: | United States: Institutional Review Board |
Non-Small Cell Lung Cancer Advanced Sorafenib |
Erlotinib Double-blind Placebo-controlled |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Protein Kinase Inhibitors Sorafenib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Erlotinib Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Sorafenib Neoplasms, Glandular and Epithelial |