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Phase II Study of Nimotuzumab (TheraCim-hR3) Concurrent With Cisplatin/Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 2
21 Years
70 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

Phase II Study of Nimotuzumab (TheraCim-hR3) Concurrent With Cisplatin/Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate of locally advanced HNSCC to treatment with Nimotuzumab and concurrent Cisplatin (CDDP) and Radiotherapy (RT).

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Wan-Teck Lim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center Singapore


Singapore: Health Sciences Authority

Study ID:




Start Date:

April 2008

Completion Date:

April 2013

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Squamous Cell Cancer
  • Chemoradiation
  • EGFR monoclonal antibody
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms