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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Cancer Centre, Singapore.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Wan-Teck Darren Lim, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT00702481
First received: June 19, 2008
Last updated: October 17, 2012
Last verified: October 2012
  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: Radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Cisplatin
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.
Other Name: Radiation

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Wan-Teck Darren Lim, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT00702481     History of Changes
Other Study ID Numbers: IB/NCCS-01
Study First Received: June 19, 2008
Last Updated: October 17, 2012
Health Authority: Singapore: Health Sciences Authority

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014