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

NCT ID: NCT00702481

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-28
• Study Completion Date: 2019-09-03

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nimotuzumab/CDDP/RT

Open label treatment arm of Nimotuzumab and cisplatin and radiation

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Radiation

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Other Intervention Names

TheraCim-Rh3

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innogene Kalbiotech Pte. Ltd

INDUSTRY

Sponsor Role: collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wan-Teck Lim, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Singapore

Locations

National Cancer Center Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

IB/NCCS-01

Identifier Type: -

Identifier Source: org_study_id