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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center St. Joseph Hospital Bristol-Myers Squibb |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00694603 |
The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway |
Estimated Enrollment: | 56 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lecia Sequist, MD, MPH | 617-726-7812 | |
Contact: Patricia Ostler | 617-724-7829 |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Lecia Sequist, MD, MPH | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Bruce Johnson, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Mark Huberman, MD |
Principal Investigator: | Lecia Sequist, MD, MPH | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Lecia Sequist, MD, MPH ) |
Study ID Numbers: | 06-026 |
Study First Received: | December 28, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00694603 |
Health Authority: | United States: Institutional Review Board |
cetuximab tyrosine kinase inhibitor |
Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms Lung Diseases |
Cetuximab Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |