Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
The purpose of this study is to define the response and toxicities with the addition of
 Nimotuzumab to chemoradiation for head and neck cancer.
Epidermal Growth Factor Receptor (EGFR) is overexpressed in Head and Neck Squamous Cell
 Carcinoma (HNSCC). EGFR pathway activation is associated with tumor growth, decreased
 apoptosis, and increased angiogenesis. These present a putative target for the use of EGFR
 inhibitors either in the form of small molecule inhibitors or monoclonal antibodies. Several
 studies have been advanced that suggest application of these targeted therapies show
 promising responses with little additional toxicity. The addition of EGFR monoclonal
 antibodies to radiation results in better response rates and locoregional control compared to
 radiation alone. Addition of EGFR monoclonal antibodies compared to chemotherapy alone also
 improves the response rates in patients with advanced HNSCC.

 Nimotuzumab is a humanized chimeric monoclonal antibody specific to the extracellular domain
 of EGFR. Several studies are ongoing and demonstrate promising efficacy of Nimotuzumab as
 monotherapy and in combination with radiation in HNSCC, and in combination with
 chemoradiation in Nasopharyngeal Carcinoma. This phase II clinical trial examines the
 feasibility of EGFR inhibition using Nimotuzumab in combination with concurrent
 chemoradiotherapy in locally advanced unresectable HNSCC. Successful and safe incorporation
 of an EGFR monoclonal antibody into the concurrent chemoradiation paradigm used to treat
 locally advanced HNSCC will represent an important advance in the optimisation of treatment
 for this group of patients.
Inclusion Criteria:

 -  Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and
 Neck.

 -  Locally advanced disease, unresectable disease or resectable disease where
 organ-preservation is intended

 -  Age > 18 years

 -  Adequate performance status of ECOG 0-2

 -  Life expectancy of at least 3 months

 -  Written informed consent to participate in the study

 -  Patients must have measurable disease, defined as at least one lesion that can be
 accurately measured in at least one dimension (longest diameter to be recorded) as >20
 mm with conventional techniques or as >10 mm with spiral CT scan.

 -  Patients must have normal organ and marrow function as defined below:

 -  leukocytes >3,000/uL

 -  absolute neutrophil count >1,500/uL

 -  platelets >100,000/uL

 -  total bilirubin within normal institutional limits

 -  AST(SGOT)/ALT(SGPT) < 2.5X normal . Creatinine within normal range and
 CCT(Cockcroft-Gault) > 50 ml/min

 Exclusion Criteria:

 -  Prior treatment with anti-EGFR or chemotherapy/radiotherapy

 -  Evidence of CNS metastases

 -  Poor performance status (ECOG 3-4)

 -  Evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated
 respiratory disorder, cardiac failure, hepatic decompensation, renal failure,
 nephritic syndrome, uncontrolled metabolic disorders such as diabetes mellitus,
 uncontrolled hypertension or uncontrolled significant infections)

 -  Pregnancy or breast-feeding (women of child-bearing potential)

 -  Prior severe allergic drug reactions

 -  Prior history of cancer in the last 5 years prior to enrollment, other than curatively
 treated cancer of the cervix or non-melanoma skin cancer.