search
Back to results

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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Nimotuzumab
Cisplatin
Radiation
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Squamous Cell Cancer, Chemoradiation, EGFR monoclonal antibody

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Center Singapore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab/CDDP/RT

Arm Description

Open label treatment arm of Nimotuzumab and cisplatin and radiation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the toxicities associated with this regimen

Full Information

First Posted
June 19, 2008
Last Updated
February 27, 2023
Sponsor
National Cancer Centre, Singapore
Collaborators
Innogene Kalbiotech Pte. Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00702481
Brief Title
Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2008 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
Collaborators
Innogene Kalbiotech Pte. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Head and Neck Squamous Cell Cancer, Chemoradiation, EGFR monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab/CDDP/RT
Arm Type
Experimental
Arm Description
Open label treatment arm of Nimotuzumab and cisplatin and radiation
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
TheraCim-Rh3
Intervention Description
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
Intervention Name(s)
Cisplatin
Intervention Description
Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
To assess the toxicities associated with this regimen
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan-Teck Lim, MD
Organizational Affiliation
National Cancer Center Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs