Cetuximab (C225, IMC-C225) is an epidermal growth factor receptor (EGFR) binding Fab fragment. Cetuximab is chimerized from the Fv (variable; antigen-binding) regions of the myeloma cell line 225, a mouse monoclonal antibody (mAb) that blocks the ligand-binding site of the EGFR, and a human immunoglobulin G (IgG) constant region (framework) gene segment. Cetuximab is developed by ImClone, now a fully owned subsidiary of Eli Lilly and Company. It is distributed under the trade name Erbitux in the U.S. and Canada by the drug company Bristol-Myers Squibb and outside those countries by the drug company Merck KGaA. In Japan, Merck KGaA, Bristol-Myers Squibb and Eli Lilly have a co-distribution. Erbitux had worldwide sales since it’s approval, making it a lucrative target for biosimilars developers. However biosimilars of Erbitux are not expected until 2018.
Cetuximab was approved by the Food and Drug Administration (FDA) in March 2006 for use in combination with radiation therapy for treating squamous cell carcinoma of the head and neck (SCCHN) or as a single agent in patients who have had prior platinum-based therapy. In July 2009, the FDA approved cetuximab (Erbitux) for treatment of colon cancer with wild-type KRAS, since it had little or no effect in colorectal tumors harboring a KRAS mutation (this also applied to the EGFR antibody panitumumab). This was the first genetic test to guide treatment of cancer. In July 2012, the FDA approved a real time PCR companion diagnostic test for KRAS, the Therascreen® KRAS test. The KRAS gene encodes a small G protein on the EGFR pathway. Cetuximab and other EGFR inhibitors only work on tumors in which KRAS is not mutated.
Cetuximab is the first of its kind to be approved for treating metastatic colorectal cancer. Cetuximab binds specifically to the EGFR (also known as erbB-1, HER1), which is expressed on both tumor and normal cells and competitively inhibits the binding of its natural ligands such as epidermal growth factor as well as other factors including transforming growth factor-α (TGF-α). Since the expression of EGFR is elevated on many types of solid tumor cells including those from the colon and rectum, Cetuximab’s inhibitory effect is more pronounced on tumor cells than on normal cells. Binding of Cetuximab to EGFR blocks the phosphorylation and activation of receptor-associated tyrosine kinase (normally following the binding of the natural ligands) and consequently leads to the inhibition of tumor cell growth, induction of apoptosis and a reduction in the production of matrix metalloproteinases and vascular endothelial growth factor. EGFR is a member of a subfamily of type I receptor tyrosine kinases that include HER1 (EGFR), HER2, HER3, and HER4. EGFR is actively expressed in some types of tissues including skin and hair follicles, which is the possible basis by which the use of Cetuximab results in the adverse reaction of a skin rash in a large percentage of patients (88%) after receiving the drug. In summary, Cetuximab inhibits receptor tyrosine kinase activity, endocytoses EGFR, inhibits cell cycle regulation, induces apoptosis, inhibits angiogenesis, inhibits invasion/metastasis, and inhibits cell repair or recovery after chemotherapy or radiation.
Fig.1 Mechanism of action of Cetuximab
Table 1. Clinical Projects of Cetuximab*
NCT ID | Status | Conditions | Lead Sponsor | Update Time |
NCT03126708 | Recruiting | Esophageal Cancer, Squamous Cell, Cetuximab Effect, Chemotherapy Effect | Peking University | April 24, 2017 |
NCT03524820 | Recruiting | Cancer of Colon | Hadassah Medical Organization | May 15, 2018 |
NCT02296203 | Active, not recruiting | Metastatic Colorectal Cancer | Gruppo Oncologico del Nord-Ovest | November 20, 2014 |
NCT01801904 | Active, not recruiting | Metastatic Colorectal Cancer | National Cancer Institute, Naples | March 1, 2013 |
NCT01832467 | Active, not recruiting | Metastatic Colorectal Cancer | Chinese University of Hong Kong | April 16, 2013 |
NCT02953782 | Recruiting | Colorectal Neoplasms, Solid Tumors | Forty Seven, Inc. | November 3, 2016 |
NCT02117466 | Recruiting | Metastatic Colorectal Cancer | VU University Medical Center | April 21, 2014 |
NCT02499120 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck (SCCHN) | Pfizer | July 15, 2015 |
NCT01719380 | Active, not recruiting | Colorectal Cancer | Array BioPharma | November 1, 2012 |
NCT03667482 | Recruiting | Head and Neck Squamous Cell Cancer, Recurrent Head and Neck Squamous Cell Cancer, Metastatic Head and Neck Squamous Cell Cancer | Memorial Sloan Kettering Cancer Center | September 12, 2018 |
NCT03134846 | Recruiting | Head and Neck Squamous Cell Carcinoma, Margin Assessment | University Medical Center Groningen | May 1, 2017 |
NCT03446157 | Recruiting | Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic | UNC Lineberger Comprehensive Cancer Center | February 26, 2018 |
NCT02717923 | Recruiting | Colorectal Neoplasms | Huazhong University of Science and Technology | March 24, 2016 |
NCT02282371 | Active, not recruiting | Head and Neck Squamous Cell Cancer | Memorial Sloan Kettering Cancer Center | November 4, 2014 |
NCT03391934 | Recruiting | Metastatic Colorectal Cancer | Cinnagen | January 5, 2018 |
NCT03524326 | Recruiting | Head and Neck Squamous Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, Head and Neck Cancer, Head and Neck Carcinoma | Memorial Sloan Kettering Cancer Center | May 14, 2018 |
NCT01693159 | Recruiting | Pain | National Center for Tumor Diseases, Heidelberg | September 26, 2012 |
NCT03401957 | Recruiting | Colorectal Cancer, Drug Resistance, Mass Spectrometry, RAS-RAF Pathway Deregulation | National Health Research Institutes, Taiwan | January 17, 2018 |
NCT01871311 | Recruiting | Colorectal Cancer, Head and Neck Cancer | Georgetown University | June 6, 2013 |
NCT01251536 | Active, not recruiting | Colorectal Cancer | Universitaire Ziekenhuizen Leuven | December 2, 2010 |
NCT01592721 | Active, not recruiting | Squamous Cell Carcinoma, Head and Neck Cancer | Anand B. Karnad | May 7, 2012 |
NCT03391843 | Active, not recruiting | Rectal Cancer Stage III | RenJi Hospital | January 5, 2018 |
NCT02095054 | Active, not recruiting | Advanced Cancers | M.D. Anderson Cancer Center | March 24, 2014 |
NCT01025089 | Active, not recruiting | Thymoma, Thymic Carcinoma, Clinical Masaoka Stage II to IVA | Memorial Sloan Kettering Cancer Center | December 3, 2009 |
NCT02054442 | Recruiting | Squamous Cell Carcinoma of the Head and Neck | Radboud University | February 4, 2014 |
NCT03717155 | Recruiting | Squamous Non-Small Cell Lung Cancer | Merck KGaA, Darmstadt, Germany | October 24, 2018 |
NCT01787500 | Active, not recruiting | Advanced Cancers | M.D. Anderson Cancer Center | February 8, 2013 |
NCT03254927 | Recruiting | Advanced Head and Neck Squamous Cell Carcinoma | Celldex Therapeutics | August 21, 2017 |
NCT03498378 | Recruiting | Head and Neck Squamous Cell Carcinoma | Kathryn Gold | April 13, 2018 |
NCT03290937 | Recruiting | Malignant Neoplasms of Digestive Organs, Colorectal Cancer | M.D. Anderson Cancer Center | September 25, 2017 |
NCT03493048 | Recruiting | Colo-rectal Cancer, Liver Metastases | Sun Yat-sen University | April 10, 2018 |
NCT03082534 | Recruiting | HNSCC, Lip SCC, Oral Cavity Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer, Nasopharynx Cancer, Sinonasal Carcinoma, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma | Assuntina G. Sacco | March 17, 2017 |
NCT01640444 | Active, not recruiting | Colorectal Cancer Metastatic | Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) | July 13, 2012 |
NCT03769311 | Not yet recruiting | Head and Neck Cancer, Squamous Cell Carcinoma | University of Wisconsin, Madison | December 7, 2018 |
NCT03325738 | Recruiting | Squamous Cell Cutaneous Carcinoma of the Skin | Centre Antoine Lacassagne | October 30, 2017 |
NCT01552434 | Recruiting | Advanced Malignant Neoplasm, Castleman Disease, Digestive System Carcinoma, Erdheim-Chester Disease, Lip and Oral Cavity Carcinoma, Lymphangioleiomyomatosis, Malignant Endocrine Neoplasm, Malignant Female Reproductive System Neoplasm, Malignant Male Reproductive System Neoplasm, Malignant Neoplasm, Malignant Respiratory Tract Neoplasm, Malignant Thoracic Neoplasm, Malignant Urinary System Neoplasm, Mesothelial Neoplasm, Metastatic Malignant Neoplasm, Metastatic Urothelial Carcinoma, Neurofibromatosis Type 2, Recurrent Adult Soft Tissue Sarcoma, Recurrent Breast Carcinoma, Recurrent Childhood Soft Tissue Sarcoma, Recurrent Digestive System Carcinoma, Recurrent Female Reproductive System Carcinoma, Recurrent Male Reproductive System Carcinoma, Recurrent Malignant Neoplasm, Recurrent Pharyngeal Carcinoma, Recurrent Thyroid Gland Carcinoma, Refractory Malignant Neoplasm, Soft Tissue Neoplasm, Stage III Breast Cancer AJCC v7, Stage III Pharyngeal Cancer, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7, Stage IV Pharyngeal Cancer, Stage IVA Pharyngeal Cancer, Stage IVB Pharyngeal Cancer, Stage IVC Pharyngeal Cancer, Thyroid Gland Neoplasm | M.D. Anderson Cancer Center | March 13, 2012 |
NCT02124707 | Active, not recruiting | Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck | UNC Lineberger Comprehensive Cancer Center | April 28, 2014 |
NCT01621217 | Active, not recruiting | Locally Advanced Cancer in the Anal Region | Lund University Hospital | June 18, 2012 |
NCT02978313 | Not yet recruiting | Colorectal Cancer | Ruijin Hospital | November 30, 2016 |
NCT01969877 | Active, not recruiting | Locally Advanced Head and Neck Cancer | Lund University Hospital | October 25, 2013 |
NCT01802645 | Recruiting | Colorectal Cancer | Technische Universität Dresden | March 1, 2013 |
NCT03457896 | Recruiting | Metastatic Colorectal Cancer | NSABP Foundation Inc | March 8, 2018 |
NCT02063529 | Recruiting | Metastatic Colorectal Cancer | Sun Yat-sen University | February 14, 2014 |
NCT02128906 | Recruiting | Squamous Cell Carcinoma | Dwight Heron | May 1, 2014 |
NCT02324608 | Recruiting | Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin | Rutgers, The State University of New Jersey | December 24, 2014 |
NCT03370276 | Recruiting | Squamous Cell Carcinoma of the Oropharynx, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Hypopharynx, Squamous Cell Carcinoma of the Paranasal Sinus, Head and Neck Squamous Cell Carcinoma, Squamous Cell Cancer, Head and Neck Carcinoma | H. Lee Moffitt Cancer Center and Research Institute | December 12, 2017 |
NCT02713373 | Recruiting | Recurrent Colorectal Carcinoma, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer | Roswell Park Cancer Institute | March 18, 2016 |
NCT03051906 | Not yet recruiting | Head and Neck Neoplasms | Azienda Ospedaliero-Universitaria Careggi | February 14, 2017 |
NCT01884259 | Active, not recruiting | Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Squamous Cell Carcinoma of the Larynx Stage III, Squamous Cell Carcinoma of the Larynx Stage IV, Squamous Cell Carcinoma of the Oropharynx Stage III, Squamous Cell Carcinoma of the Oropharynx Stage IV, Squamous Cell Carcinoma of the Oral Cavity Stage III, Squamous Cell Carcinoma of the Oral Cavity Stage IV | Arbeitsgemeinschaft medikamentoese Tumortherapie | June 24, 2013 |
NCT02101034 | Recruiting | Carcinoma, Squamous Cell of Head and Neck | Washington University School of Medicine | April 1, 2014 |
NCT02942706 | Not yet recruiting | Colorectal Cancer | Ruijin Hospital | October 24, 2016 |
NCT03727724 | Active, not recruiting | Carcinoma, Non-Small-Cell Lung | The Netherlands Cancer Institute | November 1, 2018 |
NCT02404935 | Recruiting | Metastatic Colorectal Cancer | UNICANCER | April 1, 2015 |
NCT01012609 | Active, not recruiting | Brain Cancer | Memorial Sloan Kettering Cancer Center | November 13, 2009 |
NCT02716311 | Recruiting | Non Small Cell Lung Cancer | Intergroupe Francophone de Cancerologie Thoracique | March 23, 2016 |
NCT03485638 | Recruiting | Tumor Disease Including Colorectal Cancer, Head & Neck Squamous Cell Carcinoma | Yonsei University | April 2, 2018 |
NCT03774680 | Recruiting | Colon Cancer, Colo-rectal Cancer | Ahmed A. H. Abdellatif | December 13, 2018 |
NCT03174405 | Active, not recruiting | Metastatic Colorectal Cancer | AIO-Studien-gGmbH | June 2, 2017 |
NCT03024489 | Recruiting | Head and Neck Cancer, Locally Advanced, Unresectable | Mahidol University | January 18, 2017 |
NCT02999087 | Recruiting | HNSCC | Groupe Oncologie Radiotherapie Tete et Cou | December 21, 2016 |
NCT02277197 | Active, not recruiting | Carcinoma, Squamous Cell of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head And Neck | James J Lee | October 28, 2014 |
NCT01716416 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck | Washington University School of Medicine | October 29, 2012 |
NCT02429089 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | April 29, 2015 |
NCT01154920 | Active, not recruiting | Head and Neck Squamous Cell Carcinoma | M.D. Anderson Cancer Center | July 1, 2010 |
NCT02268695 | Active, not recruiting | Head and Neck Squamous Cell Carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | October 20, 2014 |
NCT03693170 | Not yet recruiting | BRAF V600E-mutant Metastatic Colorectal Cancer | Pierre Fabre Medicament | October 2, 2018 |
NCT02938273 | Recruiting | Carcinoma, Squamous Cell of Head and Neck | The Netherlands Cancer Institute | October 19, 2016 |
NCT03087071 | Recruiting | Colorectal Cancer | M.D. Anderson Cancer Center | March 22, 2017 |
NCT01696955 | Active, not recruiting | Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma | National Cancer Institute (NCI) | October 2, 2012 |
NCT03422536 | Recruiting | Head and Neck Basaloid Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Unknown Primary Origin, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Head and Neck Cancer, Oropharyngeal Cancer, HNSCC, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma | University of Arizona | February 5, 2018 |
NCT01254617 | Active, not recruiting | Recurrent Colon Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Laryngeal Verrucous Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary, Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma, Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma, Recurrent Oral Cavity Verrucous Carcinoma, Recurrent Oropharyngeal Squamous Cell Carcinoma, Recurrent Rectal Carcinoma, Recurrent Salivary Gland Carcinoma, Salivary Gland Squamous Cell Carcinoma, Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary, Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Verrucous Carcinoma AJCC v7, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVA Major Salivary Gland Cancer AJCC v7, Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVA Oral Cavity Cancer AJCC v6 and v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Verrucous Carcinoma AJCC v7, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVB Major Salivary Gland Cancer AJCC v7, Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVB Oral Cavity Cancer AJCC v6 and v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Rectal Cancer AJCC v7, Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVC Laryngeal Verrucous Carcinoma AJCC v7, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7, Stage IVC Major Salivary Gland Cancer AJCC v7, Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma AJCC v7, Stage IVC Oral Cavity Cancer AJCC v6 and v7, Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7, Tongue Carcinoma, Untreated Metastatic Squamous Cell Carcinoma to Neck With Occult Primary | National Cancer Institute (NCI) | December 6, 2010 |
NCT01855451 | Active, not recruiting | HPV Positive Oropharyngeal Squamous Cell Carcinoma | Trans-Tasman Radiation Oncology Group (TROG) | May 16, 2013 |
NCT02861898 | Recruiting | Glioblastoma, Brain Cancer, Brain Neoplasm, Brain Tumor, Brain Neoplasm, Malignant, EGFR Gene Overexpression, GBM | Northwell Health | August 10, 2016 |
NCT03691714 | Recruiting | Recurrent Head and Neck Cancer, Head and Neck Cancer, Head and Neck Neoplasms, Metastatic Cancer | Trisha Wise-Draper | October 2, 2018 |
NCT02515734 | Not yet recruiting | Colorectal Cancer | Japan Clinical Cancer Research Organization | August 5, 2015 |
NCT03286738 | Recruiting | Metastatic Colorectal Cancer | Joong Bae Ahn | September 18, 2017 |
NCT01874171 | Active, not recruiting | Oropharyngeal Squamous Cell Carcinoma | University of Warwick | June 10, 2013 |
NCT03031444 | Recruiting | Colorectal Cancer Stage IV, Metastasis | Beijing Cancer Hospital | January 25, 2017 |
NCT02624128 | Recruiting | Squamous Cell Carcinoma of the Head and Neck | National Cancer Institute, Naples | December 8, 2015 |
NCT00316888 | Active, not recruiting | Anal Cancer | ECOG-ACRIN Cancer Research Group | April 21, 2006 |
NCT02643550 | Recruiting | Head and Neck Neoplasms | Innate Pharma | December 31, 2015 |
NCT03109158 | Recruiting | Carcinoma, Squamous Cell of Head and Neck | NanoCarrier Co., Ltd. | April 12, 2017 |
NCT02934529 | Recruiting | Metastatic Colorectal Cancer | Ludwig-Maximilians - University of Munich | October 17, 2016 |
NCT02979977 | Recruiting | Squamous Cell Cancers of the Head and Neck | Yale University | December 2, 2016 |
NCT02484833 | Recruiting | Antineoplastic Agents | Carlo Barone | June 30, 2015 |
NCT02164916 | Active, not recruiting | Colorectal Cancer | Southwest Oncology Group | June 17, 2014 |
NCT02633176 | Recruiting | Nasopharyngeal Carcinoma | Sun Yat-sen University | December 17, 2015 |
NCT01302834 | Active, not recruiting | Head and Neck Cancer, Precancerous Condition | Radiation Therapy Oncology Group | February 24, 2011 |
NCT02270814 | Recruiting | Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Head and Neck | Washington University School of Medicine | October 21, 2014 |
NCT01935921 | Active, not recruiting | Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7, Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7, Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7 | National Cancer Institute (NCI) | September 5, 2013 |
NCT01468896 | Active, not recruiting | Head and Neck Squamous Cell Carcinoma | National Cancer Institute (NCI) | November 10, 2011 |
NCT02707588 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck | Groupe Oncologie Radiotherapie Tete et Cou | March 14, 2016 |
NCT01979211 | Active, not recruiting | Head and Neck Cancer | University of Cincinnati | November 8, 2013 |
NCT00999700 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck | Gruppo Oncologico del Nord-Ovest | October 22, 2009 |
NCT03608046 | Not yet recruiting | Colorectal Neoplasms, Malignant | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | July 31, 2018 |
NCT02052960 | Active, not recruiting | Carcinoma, Squamous Cell of Head and Neck | Glycotope GmbH | February 3, 2014 |
NCT00997009 | Active, not recruiting | Cervical Cancer | National Cancer Institute, Naples | October 16, 2009 |
NCT01816984 | Active, not recruiting | Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, Recurrent Squamous Cell Carcinoma of the Nasopharynx, Recurrent Squamous Cell Carcinoma of the Oropharynx, Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer | University of Chicago | March 22, 2013 |
NCT01437449 | Active, not recruiting | Head and Neck Cancer | Stanford University | September 20, 2011 |
NCT01243372 | Active, not recruiting | Colorectal Cancer | Alliance for Clinical Trials in Oncology | November 18, 2010 |
NCT03365882 | Recruiting | Colon Adenocarcinoma, ERBB2 Gene Amplification, Rectal Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage III Colon Cancer AJCC v7, Stage III Rectal Cancer AJCC v7, Stage IIIA Colon Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7, Stage IIIB Colon Cancer AJCC v7, Stage IIIB Rectal Cancer AJCC v7, Stage IIIC Colon Cancer AJCC v7, Stage IIIC Rectal Cancer AJCC v7, Stage IV Colon Cancer AJCC v7, Stage IV Rectal Cancer AJCC v7, Stage IVA Colon Cancer AJCC v7, Stage IVA Rectal Cancer AJCC v7, Stage IVB Colon Cancer AJCC v7, Stage IVB Rectal Cancer AJCC v7 | Southwest Oncology Group | December 7, 2017 |
NCT02800486 | Recruiting | Glioblastoma, Anaplastic Astrocytoma, Anaplastic Oligoastrocytoma, Glioma, Brain Neoplasm, Brain Cancer, Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Malignant | Northwell Health | June 15, 2016 |
NCT02438722 | Active, not recruiting | Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer | Southwest Oncology Group | May 8, 2015 |
NCT02822482 | Recruiting | Carcinoma, Squamous Cell of Head and Neck | UNICANCER | July 4, 2016 |
NCT02438995 | Recruiting | Carcinoma, Squamous Cell, Carcinoma, Squamous Cell of Head and Neck | Northwell Health | May 8, 2015 |
NCT02369458 | Recruiting | Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck | Washington University School of Medicine | February 24, 2015 |
NCT01864772 | Active, not recruiting | Metastatic or Recurrent Head and Neck Squamous Cell Cancer | Groupe Oncologie Radiotherapie Tete et Cou | May 30, 2013 |
NCT01860430 | Active, not recruiting | Cancer of Head and Neck | Robert Ferris | May 22, 2013 |
NCT02255097 | Active, not recruiting | Head and Neck Squamous Cell Carcinoma | Merck Sharp & Dohme Corp. | October 2, 2014 |
NCT02383966 | Active, not recruiting | Carcinoma, Squamous Cell of Head and Neck | Merck KGaA, Darmstadt, Germany | March 10, 2015 |
NCT00956007 | Active, not recruiting | Head and Neck Cancer | Radiation Therapy Oncology Group | August 11, 2009 |
NCT01810913 | Active, not recruiting | Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Squamous Cell Carcinoma of the Oropharynx, Stage III Verrucous Carcinoma of the Larynx, Stage III Verrucous Carcinoma of the Oral Cavity, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Tongue Cancer | Radiation Therapy Oncology Group | March 14, 2013 |
NCT01884623 | Active, not recruiting | Head Neck Cancer Squamous Cell Recurrent | Gustave Roussy, Cancer Campus, Grand Paris | June 24, 2013 |
NCT00265850 | Active, not recruiting | Colorectal Cancer | Alliance for Clinical Trials in Oncology | December 15, 2005 |
NCT01104922 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck | Dwight Heron | April 16, 2010 |
NCT00904345 | Active, not recruiting | Head and Neck Cancer | University of Michigan Cancer Center | May 19, 2009 |
NCT02627274 | Recruiting | Solid Tumor, Breast Cancer, Cancer of Head and Neck | Hoffmann-La Roche | December 10, 2015 |
NCT03356223 | Recruiting | Head and Neck Cancer, Advanced Cancer, Metastatic Cancer | Centre Leon Berard | November 29, 2017 |
NCT02057107 | Recruiting | Recurrent, Head and Neck Cancer | University of Pittsburgh | February 6, 2014 |
NCT01950689 | Recruiting | Head and Neck Squamous Cell Carcinoma | The Christie NHS Foundation Trust | September 25, 2013 |
NCT00655876 | Active, not recruiting | Esophageal Cancer | Radiation Therapy Oncology Group | April 10, 2008 |
NCT03688230 | Not yet recruiting | Metastatic Colorectal Cancer | SFJ Pharmaceuticals X, LTD. | September 28, 2018 |
NCT02928224 | Recruiting | BRAF V600E-mutant Metastatic Colorectal Cancer | Array BioPharma | October 10, 2016 |
NCT00736944 | Active, not recruiting | Squamous Cell Carcinoma of the Head and Neck | Washington University School of Medicine | August 18, 2008 |
NCT01079780 | Active, not recruiting | Colorectal Cancer | Pam Cogliano | March 3, 2010 |
NCT02292758 | Active, not recruiting | olorectal Adenocarcinoma, RAS Wild Type, Stage IV Colorectal Cancer AJCC v7, Stage IVA Colorectal Cancer AJCC v7, Stage IVB Colorectal Cancer AJCC v7 | Academic and Community Cancer Research United | November 17, 2014 |
NCT00183898 | Active, not recruiting | Gastric Cancer, Esophageal Cancer | University of Southern California | September 16, 2005 |
NCT01442649 | Active, not recruiting | Colorectal Cancer | UNICANCER | September 28, 2011 |
NCT00265941 | Active, not recruiting | Head and Neck Cancer | Radiation Therapy Oncology Group | December 15, 2005 |
NCT00533949 | Active, not recruiting | Lung Cancer, Radiation Toxicity | Radiation Therapy Oncology Group | September 24, 2007 |
NCT03494322 | Recruiting | Head and Neck Cancer, Squamous Cell Carcinoma | University College, London | April 11, 2018 |
NCT00946712 | Active, not recruiting | Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Squamous Cell Lung Carcinoma, Stage IV Large Cell Lung Carcinoma, Stage IV Lung Adenocarcinoma, Stage IV Squamous Cell Lung Carcinoma | Southwest Oncology Group | July 27, 2009 |
NCT03405272 | Not yet recruiting | Metastatic Colorectal Cancer | Sinocelltech Ltd. | January 23, 2018 |
NCT03652233 | Not yet recruiting | Recurrent Squamous Cell Carcinoma of the Head or Neck, Platinum- and Cetuximab-Refractory Squamous Cell Carcinoma of the Head or Neck, Metastatic Squamous Cell Carcinoma of the Head or Neck, Squamous Cell Carcinoma | Vanderbilt-Ingram Cancer Center | August 29, 2018 |
NCT01233843 | Active, not recruiting | Squamous Cell Head and Neck Carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | November 3, 2010 |
NCT01884740 | Recruiting | Glioblastoma Multiforme, Fibrillary Astrocytoma of Brain, Glioma of Brainstem, Anaplastic Astrocytoma, Pilomyxoid Astrocytoma, Mixed Oligodendroglioma-Astrocytoma, Brain Stem Glioma, Diffuse Intrinsic Pontine Glioma | Weill Medical College of Cornell University | June 24, 2013 |
NCT00248287 | Active, not recruiting | Metastatic Breast Cancer | US Oncology Research | November 3, 2005 |
NCT01440270 | Active, not recruiting | Locally Advanced Malignant Neoplasm, Oral Cancer, Oropharyngeal Carcinoma | Shanghai Jiao Tong University School of Medicine | September 26, 2011 |
NCT00609284 | Active, not recruiting | HNSCC | Groupe Oncologie Radiotherapie Tete et Cou | February 7, 2008 |
NCT02845856 | Recruiting | Recurrent Non-small Cell Lung Cancer | Fuda Cancer Hospital, Guangzhou | July 27, 2016 |
NCT02507154 | Recruiting | Nasopharyngeal Cancer, Head and Neck Squamous Cell Carcinoma | National University Hospital, Singapore | July 23, 2015 |
NCT03727763 | Recruiting | Colorectal Cancer | Shanghai Changzheng Hospital | November 1, 2018 |
NCT03356158 | Recruiting | Metastatic Colorectal Cancer | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | November 29, 2017 |
NCT02636088 | Active, not recruiting | Esophageal Neoplasm | Gabriella Alexandersson von Döbeln | December 21, 2015 |
NCT03646461 | Not yet recruiting | Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck | University of California, San Diego | August 24, 2018 |
NCT01412229 | Active, not recruiting | Head and Neck Cancer | UNC Lineberger Comprehensive Cancer Center | August 9, 2011 |
NCT02236936 | Recruiting | Squamous Cell Carcinoma of the Hypopharynx Stage III, Squamous Cell Carcinoma of the Hypopharynx Stage IV, Laryngeal Squamous Cell Carcinoma Stage III, Laryngeal Squamous Cell Carcinoma Stage IV, Oropharyngeal Squamous Cell Carcinoma Stage III, Oropharyngeal Squamous Cell Carcinoma Stage IV, Squamous Cell Carcinoma of the Oral Cavity Stage III, Squamous Cell Carcinoma of the Oral Cavity Stage IV, Locally Advanced Malignant Neoplasm | Arbeitsgemeinschaft medikamentoese Tumortherapie | September 11, 2014 |
NCT01393821 | Active, not recruiting | Dermatologic Complications, Malignant Neoplasm, Pain | Mayo Clinic | July 13, 2011 |
NCT00543504 | Active, not recruiting | Advanced Cancer | M.D. Anderson Cancer Center | October 15, 2007 |
NCT03532737 | Recruiting | Locally Advanced Head and Neck Cancer | Kuwait Cancer Control Center | May 22, 2018 |
NCT01874860 | Recruiting | Colorectal Cancer, Head and Neck Cancer | University of Louisville | June 11, 2013 |
NCT01867697 | Active, not recruiting | Metastatic Colorectal Cancer | Per Pfeiffer | June 4, 2013 |
NCT02826837 | Not yet recruiting | Advanced Colorectal Cancer | Taiwan Leader Biotech Corp. | July 11, 2016 |
NCT01059188 | Active, not recruiting | Lung Cancer | Swiss Group for Clinical Cancer Research | January 29, 2010 |
NCT01726309 | Recruiting | Colorectal Cancer, Non-Small Cell Lung Cancer | Cancer Trials Ireland | November 14, 2012 |
NCT02741570 | Recruiting | Head and Neck Cancer | Bristol-Myers Squibb | April 18, 2016 |
NCT01588431 | Active, not recruiting | Carcinoma, Squamous Cell of Head and Neck | Anand B. Karnad | May 1, 2012 |
NCT01737450 | Recruiting | Head and Neck Neoplasms, Neoplasm Metastasis, Recurrent Disease, Progressive Disease | Centre Leon Berard | November 29, 2012 |
NCT01675999 | Recruiting | Colon Cancer, Locally Advanced Malignant Neoplasm | Assistance Publique - Hôpitaux de Paris | August 30, 2012 |
NCT01097642 | Active, not recruiting | Breast Cancer | Jenny C. Chang, MD | April 1, 2010 |
NCT03603379 | Not yet recruiting | Glioblastoma | University Hospital, Basel, Switzerland | July 27, 2018 |
NCT03426371 | Recruiting | Metastatic Colorectal Cancer | Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | February 8, 2018 |
NCT01420874 | Active, not recruiting | Colorectal Cancer, Cancer of Pancreas, Pancreatic Neoplasm, Malignant Neoplasm of Large Intestine, Malignant Tumor of Colon, Colon Carcinoma, Cancer of Colon, Pancreatic Cancer | Barbara Ann Karmanos Cancer Institute | August 22, 2011 |
NCT03692520 | Not yet recruiting | Advanced Solid Tumors | Sinocelltech Ltd. | October 2, 2018 |
NCT03692689 | Recruiting | Triple Negative Breast Neoplasms | Sinocelltech Ltd. | October 2, 2018 |
NCT03146338 | Recruiting | Metastatic Colorectal Cancer, Metastatic Head and Neck Cancer | Weprom | May 9, 2017 |
NCT03744208 | Not yet recruiting | Head and Neck Squamous Cell Carcinoma | Shi Yuankai | November 16, 2018 |
NCT03713372 | Not yet recruiting | Head and Neck Cancer | Sinocelltech Ltd. | October 19, 2018 |
NCT03717038 | Not yet recruiting | Metastatic Colorectal Cancer, Colorectal Cancer Metastatic, Carcinoma | Symphogen A/S | October 23, 2018 |
NCT03549338 | Active, not recruiting | Metastatic Colorectal Cancer, Colorectal Cancer Metastatic, Carcinoma | Symphogen A/S | June 8, 2018 |
NCT02948985 | Not yet recruiting | Colorectal Cancer Metastatic | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | October 31, 2016 |
NCT03666325 | Not yet recruiting | Skin Neoplasm | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | September 11, 2018 |
Table 2. Approved Drugs of Cetuximab**
INN (trade name) | Therapeutic area | Dose | Strength | Route | Company | Marketing start | Market |
Erbitux | Head and Neck Cancer; Colorectal Cancer; K-Ras Wild-Type, EGFR-Expressing, Metastatic Colorectal Cancer | Solution | 2 mg / mL | Intravenous infusion | ImClone | February 12, 2004 | |
Erbitux | Head and Neck Neoplasms, Colorectal Neoplasms | Solution | 5 mg / mL | Intravenous infusion | Merck KGaA | June 29, 2004 | |
Erbitux | EGFR-Expressing, RAS Wild-Type Metastatic Colorectal Cancer; Squamous Cell Carcinoma of the Head and Neck | Solution | 2 mg / mL | Intravenous infusion | ImClone LLC | October 28, 2008 | |
Erbitux | EGFR-Expressing, RAS Wild-Type Metastatic Colorectal Cancer, Squamous Cell Cancer of The Head and Neck | Solution | 5 mg / mL | Intravenous infusion | Merck Serono Australia Pty Ltd | September 25, 2007 | |
Erbitux | EGFR-Expressing, RAS Wild-Type Metastatic Colorectal Cancer, Squamous Cell Cancer of The Head and Neck | Solution | 5 mg / mL | Intravenous infusion | Merck Serono | July 16, 2008 |
Reference
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?cond=&term=Cetuximab
** Information presented in the table were collected from the following website:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125084
https://www.ema.europa.eu/en/medicines/human/EPAR/erbitux
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=132393
https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=75672
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/4291415A1
For research use only. Not intended for any clinical use.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.