Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer - Full Text View

Sponsored by:	National Cancer Centre, Singapore
Information provided by:	National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:	NCT00702481

Purpose

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	Intervention	Phase
Head and Neck Cancer	Drug: Nimotuzumab Drug: Cisplatin Radiation: Radiotherapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
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)

Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:

To determine the response rate of locally advanced HNSCC to treatment with Nimotuzumab and concurrent Cisplatin (CDDP) and Radiotherapy (RT). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the toxicities associated with this regimen [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	37
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nimotuzumab/CDDP/RT: Experimental Open label treatment arm	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. Drug: Cisplatin Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy. Radiation: Radiotherapy 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.

Arms

Assigned Interventions

Nimotuzumab/CDDP/RT: Experimental

Open label treatment arm

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.

Drug: Cisplatin

Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.

Radiation: Radiotherapy

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.

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.

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702481

Contacts

Contact: Wan-Teck Lim, MD	+65-64368200	dmolwt@nccs.com.sg
Contact: Eng-Huat Tan, MD	+65-64368171	dmoteh@nccs.com.sg

Locations

Singapore
National Cancer Center Singapore	Recruiting
Singapore, Singapore, 169610
Principal Investigator: Wan-Teck Lim, MD

Sponsors and Collaborators

National Cancer Centre, Singapore

Investigators

Principal Investigator:

Wan-Teck Lim, MD

National Cancer Center Singapore

More Information

No publications provided

Responsible Party:	National Cancer Center Singapore ( Dr Wan-Teck Darren Lim )
Study ID Numbers:	IB/NCCS-01
Study First Received:	June 19, 2008
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00702481 History of Changes
Health Authority:	Singapore: Health Sciences Authority

Keywords provided by National Cancer Centre, Singapore:

Head and Neck Squamous Cell Cancer
Chemoradiation
EGFR monoclonal antibody

Study placed in the following topic categories:

Carcinoma, Squamous Cell of Head and Neck
Squamous Cell Carcinoma
Carcinoma
Antibodies, Monoclonal
Antibodies
Cisplatin
Radiation-Sensitizing Agents

Head and Neck Neoplasms
Epidermoid Carcinoma
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site

Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009