Status:
COMPLETED
Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
Lead Sponsor:
National Cancer Centre, Singapore
Collaborating Sponsors:
Innogene Kalbiotech Pte. Ltd
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00702481
Start Date
April 28 2008
End Date
September 3 2019
Last Update
February 28 2023
Active Locations (1)
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1
National Cancer Center Singapore
Singapore, Singapore, 169610