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Sponsors and Collaborators: |
Brown University Memorial Hospital of Rhode Island |
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Information provided by: | Brown University |
ClinicalTrials.gov Identifier: | NCT00787852 |
The purpose of this study is to evaluate if a maximum dose of 100 mg of dasatinib with concurrent chemoradiation can be tolerated in patients with chemotherapy naive stage III NSCLC in separate cohorts of locally advanced and potentially resectable disease.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Dasatinib, Carboplatin, Paclitaxel |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Dasatinib With Concurrent Chemoradiation for Stage III NSCLC Principal Investigator: Howard Safran, MD. |
Estimated Enrollment: | 36 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Describe the safety of maintenance dasatinib, 100 mg/day for 2 years, in patients with stage III NSCLC.
For patients with potentially resectable disease, to assess the pathologic complete response following neoadjuvant dasatinib, paclitaxel, carboplatin and 50.4 Gy concurrent radiation.
For patients with locally unresectable disease, to obtain radiographic response data following dasatinib, paclitaxel, carboplatin and 64.8 Gy radiation.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
Exclusion Criteria:
Cardiac Symptoms; any of the following should be considered for exclusion:
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin.
Responsible Party: | Brown University Oncology Group ( Teresa A. Kennedy, Administrative Director, BrUOG ) |
Study ID Numbers: | BrUOG-NSCL-216 |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00787852 History of Changes |
Health Authority: | United States: Food and Drug Administration |
dasatinib radiation paclitaxel |
carboplatin NSCLC safety of the addition of dasatinib to chemoradiation for stage III NSCLC |
Thoracic Neoplasms Carboplatin Antimitotic Agents Protein Kinase Inhibitors Carcinoma Respiratory Tract Diseases Lung Neoplasms Paclitaxel |
Lung Diseases Dasatinib Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Dasatinib Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |