Cetuximab

Generic Name
Cetuximab
Brand Names
Erbitux
Drug Type
Biotech
Chemical Formula
-
CAS Number
205923-56-4
Unique Ingredient Identifier
PQX0D8J21J
Background

Cetuximab is a recombinant chimeric human/mouse IgG1 monoclonal antibody that competitively binds to epidermal growth factor receptor (EGFR) and competitively inhibits the binding of epidermal growth factor (EGF). EGFR is a member of the ErbB family of receptor tyrosine kinases found in both normal and tumour cells; it is responsible for regulating epithelial tissue development and homeostasis. EGFR has been implicated in various types of cancer, as it is often overexpressed in malignant cells and EGFR overexpression has been linked to more advanced disease and poor prognosis. EGFR is often mutated in certain types of cancer and serves as a driver of tumorigenesis. In vitro, cetuximab was shown to mediate anti-tumour effects in numerous cancer cell lines and human tumour xenografts.

Approved by the FDA in February 2004 under the brand name ERBITUX, cetuximab is used for the treatment of head and neck cancer and metastatic, KRAS wild-type colorectal cancer, and metastatic colorectal cancer with a BRAF V600E mutation. It has also been investigated in advanced colorectal cancer, EGFR-expressing non-small cell lung cancer (NSCLC), and unresectable squamous cell skin cancer. Cetuximab is administered via intravenous infusion and is used as monotherapy or in combination with other chemotherapies, including platinum agents, radiation therapy, leucovorin, fluorouracil, and irinotecan.

Indication

Cetuximab indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. It is indicated for treating a recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. It is indicated for recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy.

Cetuximab is also indicated for K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI, a chemotherapy combination that includes leucovorin, fluorouracil, and irinotecan; in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy; or as monotherapy in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.

Additionally, cetuximab is also indicated for metastatic colorectal cancer that is BRAF V600E mutation-positive (as determined by an FDA-approved test) in combination with encorafenib but only after prior therapy.

Cetuximab is not indicated for the treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.

Associated Conditions
Locally Advanced Squamous Cell Carcinomas of the Head and Neck (SCCHN), Metastatic Colorectal Cancer (CRC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Regionally Advanced Squamous Cell Carcinoma of the Head and Neck, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Associated Therapies
-

Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)

First Posted Date
2008-10-23
Last Posted Date
2015-05-14
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
289
Registration Number
NCT00778830
Locations
🇸🇬

Research Site, Singapore, Singapore

A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel

First Posted Date
2008-10-07
Last Posted Date
2015-10-28
Lead Sponsor
Eli Lilly and Company
Registration Number
NCT00768131
Locations
🇺🇸

Local Institution, Austin, Texas, United States

Irinotecan/Cetuximab Followed by XELOX/Cetuximab vs the Reverse Sequence in Metastatic CRC

First Posted Date
2008-09-19
Last Posted Date
2013-02-13
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
68
Registration Number
NCT00755534
Locations
🇬🇷

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

🇬🇷

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

🇬🇷

University Hospital of Heraklion, Dep of Medical Oncology, Heraklion, Creta, Greece

and more 7 locations

Lohp, 5-Fu/Lv and Bevacizumab, Alternative With Cpt-11, 5-Fu/Lv and Cetuximab In Metastatic Crc

First Posted Date
2008-09-18
Last Posted Date
2015-10-07
Lead Sponsor
University Hospital of Crete
Target Recruit Count
24
Registration Number
NCT00755118
Locations
🇬🇷

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

🇬🇷

University Hospital of Crete, Dep of Medical Oncology, Heraklion, Crete, Greece

🇬🇷

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

Trial of 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head and Neck Cancer

First Posted Date
2008-08-18
Last Posted Date
2020-09-09
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
30
Registration Number
NCT00736944
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Study of FOLFIRI Plus Cetuximab Plus IMO-2055 in Patients With Colorectal Cancer

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2008-07-21
Last Posted Date
2013-10-22
Lead Sponsor
EMD Serono
Target Recruit Count
21
Registration Number
NCT00719199
Locations
🇺🇸

Georgetown University Lombardi Cancer Center, Washington, DC, District of Columbia, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

and more 2 locations

Neoadjuvant Cetuximab in HNSCC Combined With Curative Surgery

Phase 1
Completed
Conditions
Interventions
First Posted Date
2008-07-14
Last Posted Date
2012-11-14
Lead Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Target Recruit Count
34
Registration Number
NCT00714649
Locations
🇧🇪

Cliniques Universitaires St Luc-UCL, Bruxelles, Belgium

Chemoradiation Treatment for Head and Neck Cancer

First Posted Date
2008-06-25
Last Posted Date
2017-07-12
Lead Sponsor
Trans Tasman Radiation Oncology Group
Target Recruit Count
60
Registration Number
NCT00704639
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Cilengitide in Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

First Posted Date
2008-06-25
Last Posted Date
2014-04-30
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
184
Registration Number
NCT00705016
Locations
🇨🇭

Research Site, Geneva, Switzerland

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