Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

Study Overview
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Brief Summary
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This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

Official Title
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Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: C225 (cetuximab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form signed prior to study entry Age between 18-69 years old Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ) Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria Primary tumor measurable KPS score ≥80 Expected life span ≥6 months Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin <1.5×ULN Adequate renal function: Creatinine Clearance < 1.5×ULN Exclusion Criteria: Evidence of distant metastatic disease Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) Previous radiotherapy for the primary tumor or lymph nodes Previous exposure to epidermal growth factor-targeted therapy Prior chemotherapy or immunotherapy for the primary tumor Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix Any investigational agent prior to the 1st study medication Participation in another clinical study within the 30 days prior to Inclusion in this study. Peripheral neuropathy > grade 1 Known grade 3 or 4 allergic reaction to any of the study treatment History of severe pulmonary or cardiac disease Creatinine Clearance < 30ml/min Know drug abuse / alcohol abuse Legal incapacity or limited legal capacity Active systemic infection Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol Pregnancy (confirmed by serum or urine β-HCG) or lactation period Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab<br>400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy | Drug: C225 (cetuximab)<br>* one week before and then weekly during radiotherapy<br>* Other names: Erbitux;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy | The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival |  | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety., Radiotherapy, chemotherapy, Drug Targeting, loco-regionally advanced nasopharyngeal carcinoma, efficacy