Overview

This trial is active, not recruiting.

Condition head and neck cancer
Treatments nimotuzumab, cisplatin, radiation
Phase phase 2
Target EGFR
Sponsor National Cancer Centre, Singapore
Collaborator Innogene Kalbiotech Pte. Ltd
Start date April 2008
End date December 2017
Trial size 37 participants
Trial identifier NCT00702481, IB/NCCS-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Open label treatment arm of Nimotuzumab and cisplatin and radiation
nimotuzumab TheraCim-Rh3
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.
cisplatin
Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.
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 Outcomes

Measure
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 Outcomes

Measure
To assess the toxicities associated with this regimen
time frame: 16 weeks

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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.

Additional Information

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)
Principal investigator Wan-Teck Lim, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by National Cancer Centre, Singapore.