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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Bayer OSI Pharmaceuticals |
Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00609804 |
This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.
Condition | Intervention | Phase |
Non-Small Cell Lung Cancer |
Drug: Sorafenib and Erlotinib Drug: Sorafenib |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Sorafenib Sorafenib tosylate Erlotinib Erlotinib hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib |
Estimated Enrollment: | 94 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Sorafenib and Erlotinib
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Drug: Sorafenib and Erlotinib
Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
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2: Active Comparator
Sorafenib
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Drug: Sorafenib
Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
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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:
Contact: David Spigel, M.D. | (615) 329-7274 | dspigel@tnonc.com |
Contact: Trials Info | (615) 329-7274 | trialsinfo@scresearch.net |
United States, Florida | |||||
Florida Cancer Specialists | Recruiting | ||||
Fort Myers, Florida, United States, 33901 | |||||
Contact: Katie Goodman 239-274-9930 KatieG@flcancer.com | |||||
United States, Georgia | |||||
Wellstar Cancer Research | Recruiting | ||||
Marietta, Georgia, United States, 30060 | |||||
United States, Tennessee | |||||
Tennessee Oncology, PLLC | Recruiting | ||||
Nashville, Tennessee, United States, 37023 | |||||
Chattanooga Oncology Hematology Associates | Recruiting | ||||
Chattanooga, Tennessee, United States, 37404 | |||||
Contact: Research Coordiantor 423-698-1844 research@cohaonline.com | |||||
Associates in Hematology Oncology | Recruiting | ||||
Chattanooga, Tennessee, United States, 37404 |
Sarah Cannon Research Institute |
SCRI Oncology Research Consortium |
Bayer |
OSI Pharmaceuticals |
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 162 |
First Received: | January 24, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00609804 |
Health Authority: | United States: Food and Drug Administration |
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