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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Genentech Department of Defense |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00563784 |
Primary Objective:
Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. Safety is measured by the rate of grade 3 or worse nonhematological toxicities occurring prior to the beginning of consolidation therapy (including all toxicities attributed to chemoradiation occurring within 90 days of the start of radiation therapy); compliance is defined as the completion of the treatment regimen with no more than minor variations.
Secondary Objectives
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer Lung Cancer |
Drug: Erlotinib Drug: Carboplatin Drug: Paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 72 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Erlotinib + Paclitaxel + Carboplatin
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Drug: Erlotinib
150 mg by mouth daily x 7 Weeks
Drug: Carboplatin
2 AUC by vein weekly x 7 Weeks
Drug: Paclitaxel
45 mg/m^2 by vein weekly x 7 Weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with Tl or T2 disease with N2 or T3N1-2 disease (Stage IIIA) are eligible if they are deemed inoperable. Patients with T4 with any N or any T with N2 or N3 disease are eligible if unresectable.
Radiographic evidence of mediastinal lymph nodes > 2.0 cm in the largest diameter is sufficient to stage N2 or N3 disease. If the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease, then at least one of the nodes must be proven positive cytologically or histologically;
Exclusion Criteria:
Contact: Ritsuko R. Komaki, MD | 713-563-2300 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Ritsuko R. Komaki, MD |
Principal Investigator: | Ritsuko R. Komaki, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Ritsuko R. Komaki, MD/Professor ) |
Study ID Numbers: | 2005-1023 |
Study First Received: | November 21, 2007 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00563784 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Lung Cancer Squamous Cell Carcinoma Adenocarcinoma Bronchoalveolar Cell Carcinoma Large Cell Anaplastic Carcinoma Giant Cell Carcinoma Clear Cell Carcinoma Erlotinib |
Erlotinib Hydrocholoride OSI-774 Tarceva Carboplatin Paraplatin Paclitaxel Taxol NSCLC |
Erlotinib Thoracic Neoplasms Antimitotic Agents Carboplatin Squamous Cell Carcinoma Protein Kinase Inhibitors Carcinoma Adenocarcinoma, Clear Cell Carcinoma, Giant Cell Respiratory Tract Diseases Paclitaxel |
Lung Neoplasms Lung Diseases Tubulin Modulators Epidermoid Carcinoma Non-small Cell Lung Cancer Carcinoma, Squamous Cell Adenocarcinoma Antineoplastic Agents, Phytogenic 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 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 Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |