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Sponsored by: |
Fox Chase Cancer Center |
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Information provided by: | Fox Chase Cancer Center |
ClinicalTrials.gov Identifier: | NCT00315185 |
The purpose of this study is to determine the role of cetuximab (Erbitux) with chemotherapy for advanced colorectal carcinoma. This study will determine if this new agent can improve one's response to standard treatment.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study as First Line Treatment for Patients With Advanced Non-Small Cell Lung Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | December 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
This research study is being done to determine if cetuximab will improve efficacy of standard chemotherapy. This agent targets epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs in non-small-cell lung cancer (NSCLC). It has shown to be safe and can shrink tumors. There is little information about the combination of this agent with both paclitaxel and carboplatin. This study combines cetuximab with monthly carboplatin and weekly paclitaxel.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Note: Patients are considered to not be of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
United States, Pennsylvania | |
Consultants in Medical Oncology & Hematology Inc. | |
Drexel Hill, Pennsylvania, United States, 19026 |
Principal Investigator: | Corey Langer, MD | Fox Chase Cancer Center |
Study ID Numbers: | OPN-TH-017 |
Study First Received: | April 14, 2006 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00315185 History of Changes |
Health Authority: | United States: Institutional Review Board |
Advanced Non-small Cell Lung Cancer First Line Treatment |
Thoracic Neoplasms Respiratory Tract Diseases Paclitaxel Lung Neoplasms Lung Diseases Cetuximab |
Non-small Cell Lung Cancer Carboplatin Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Cetuximab Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |