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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Sanofi-Aventis Genentech |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00254384 |
Primary objectives are:
Secondary objectives are:
Condition | Intervention |
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Lung Cancer |
Drug: Erlotinib Drug: Cisplatin Drug: Docetaxel |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection |
Estimated Enrollment: | 40 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Erlotinib + Cisplatin + Docetaxel
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Drug: Erlotinib
150 mg by mouth daily for 1 year.
Drug: Cisplatin
80 mg/m^2 IV over a 30 minutes - 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
Drug: Docetaxel
75 mg/m^2 IV over a 1 hour infusion every 3 weeks (21 day cycle) for 3 cycles before surgery.
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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:
Contact: Warner Tse, R.N. | 713-563-4666 | wtse@mdanderson.org |
United States, Texas | |
University of Texas MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Warner Tse, RN 713-563-4666 wtse@mdanderson.org | |
Principal Investigator: Edward S. Kim, MD |
Principal Investigator: | Edward S. Kim, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | University of Texas M.D. Anderson Cancer Center ( Edward S. Kim, M.D./Assistant Professor ) |
Study ID Numbers: | 2004-0221 |
Study First Received: | November 14, 2005 |
Last Updated: | May 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00254384 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Lung Cancer Cisplatin Platinol Platinol-AQ CDDP |
Docetaxel Taxotere Erlotinib Tarceva OSI-774 NSCLC |
Thoracic Neoplasms Erlotinib Protein Kinase Inhibitors Carcinoma Docetaxel Respiratory Tract Diseases Cisplatin |
Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Erlotinib Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Docetaxel Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |