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| Sponsor: | Massachusetts General Hospital |
|---|---|
| Collaborators: |
Dana-Farber Cancer Institute Genentech |
| Information provided by: | Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00567359 |
Purpose
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.
Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: Erlotinib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR) |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lecia Sequist, MD, MPH | 617-726-7812 | lvsequist@partners.org |
| Contact: Patricia Ostler, RN | 617-724-7829 | postler@partners.org |
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Zeina Babetty 650-723-2983 zbabetty@stanford.edu | |
| Principal Investigator: Joel W Neal, MD PhD | |
| United States, Massachusetts | |
| Massachusetts General Hosptial | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Patricia Ostler, RN 617-724-7829 postler@partners.org | |
| Contact: Beth A Kennedy 617-724-1223 eakennedy@partners.org | |
| Principal Investigator: Lecia V. Sequist, MD, MPH | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Pasi Janne, MD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Daniel Costa, MD | |
| North Shore Medical Center | Recruiting |
| Peabody, Massachusetts, United States, 01960 | |
| Principal Investigator: Rachel Rosovsky, MD | |
| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Kristina Williams, CCRP 314-362-6963 kjwillia1@dom.wustl.edu | |
| Principal Investigator: Boone Goodgame, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York City, New York, United States, 10021 | |
| Principal Investigator: Chistopher G Azzoli, MD | |
| United States, Ohio | |
| Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Nathan A Pennell, MD PhD | |
| Principal Investigator: | Lecia V. Sequist, MD, MPH | Massachusetts General Hospital |
More Information
| Responsible Party: | Lecia Sequist, MD, MPH, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00567359 History of Changes |
| Other Study ID Numbers: | 07-259 |
| Study First Received: | November 30, 2007 |
| Last Updated: | July 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
NSCLC erlotinib epidermal growth factor receptor EGFR |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Mitogens Erlotinib Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors |