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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Bristol-Myers Squibb OSI Pharmaceuticals |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00826449 |
Primary Objectives:
Secondary Objectives:
A. To explore the relationship between clinical response to the combination of dasatinib and erlotinib and epidermal growth factor receptor (EGFR) mutational status, EGFR gene copy number, RAS mutations and expression of pSrc, pEGFR, ErbB2, ErbB3, E-cadherin, and vimentin in pre-treatment tumor biopsies.
B.To determine if there is a correlation between drug exposure, clinical response and changes in plasma levels of IL-8, bFGF, PDGF, soluble VEGFR-2, VEGF, or TNF-alpha during treatment with erlotinib and dasatinib.
Condition | Intervention | Phase |
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Lung Cancer Non-small Cell Lung Cancer |
Drug: Dasatinib Drug: Erlotinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I-II Study of Dasatinib and Erlotinib in Non-Small Cell Lung Cancer |
Estimated Enrollment: | 59 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase I: Experimental
Dasatinib + Erlotinib
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Drug: Dasatinib
Starting dose of 70 mg by mouth daily for 21 day cycle.
Drug: Erlotinib
150 mg by mouth daily every 21 day cycle.
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Faye M. Johnson, MD, PhD, BS | 713-792-6363 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Faye M. Johnson, MD, PhD, BS |
Principal Investigator: | Faye M. Johnson, MD, PhD, BS | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Faye M. Johnson, MD, PhD, BS/Assistant Professor ) |
Study ID Numbers: | 2008-0353 |
Study First Received: | January 20, 2009 |
Last Updated: | July 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00826449 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Solid Tumors Advanced Cancer Non-Small Cell Lung Cancer NSCLC Solid Tumor Malignancy Dasatinib |
BMS-354825 Sprycel® Erlotinib Erlotinib hydrochloride Tarceva OSI-774 |
Erlotinib Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Dasatinib Lung Diseases |
Non-small Cell Lung Cancer Protein Kinase Inhibitors 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 Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Dasatinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |