Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702481
Recruitment Status : Active, not recruiting
First Posted : June 20, 2008
Last Update Posted : April 25, 2018
Innogene Kalbiotech Pte. Ltd
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief Summary:
The purpose of this study is to define the response and toxicities with the addition of Nimotuzumab to chemoradiation for head and neck cancer.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Nimotuzumab Drug: Cisplatin Radiation: Radiation Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Nimotuzumab (TheraCim-hR3) Concurrent With Cisplatin/Radiotherapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Study Start Date : April 2008
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nimotuzumab/CDDP/RT
Open label treatment arm of Nimotuzumab and cisplatin and radiation
Drug: Nimotuzumab
Patients will receive nimotuzumab 200 mg weekly for 8 weeks. Nimotuzumab will be started together with concurrent chemoradiation, and continued 1 week after the completion of chemoradiation.
Other Name: TheraCim-Rh3
Drug: Cisplatin
Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.
Radiation: Radiation
Concurrent radiotherapy will be given to the primary tumor and upper neck at 2 Gy per fraction, once a day, five days a week to a total of 70 Gy in 35 fractions in seven weeks.

Primary Outcome Measures :
  1. To determine the response rate of locally advanced HNSCC to treatment with Nimotuzumab and concurrent Cisplatin (CDDP) and Radiotherapy (RT). [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. To assess the toxicities associated with this regimen [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00702481

National Cancer Center Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Innogene Kalbiotech Pte. Ltd
Principal Investigator: Wan-Teck Lim, MD National Cancer Center Singapore

Responsible Party: National Cancer Centre, Singapore Identifier: NCT00702481     History of Changes
Other Study ID Numbers: IB/NCCS-01
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Keywords provided by National Cancer Centre, Singapore:
Head and Neck Squamous Cell Cancer
EGFR monoclonal antibody

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents