Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.

Official Title
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Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma

Conditions
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Stage IV Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: cisplatin and 5-Fu combined with nimotuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic diagnosis of nasopharyngeal carcinoma Distance metastasis at least 6 months after radical treatment Not suitable for local treatment, e.g. surgery, TACE At least one measurable lesion Estimate survival >3months Range from 18～70 years old PS 0 1 WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN 0Serum creatinine < 1.5×ULN Exclusion Criteria: Central nervous system metastases Suitable for local treatment Second malignancy within 5 years Precious therapy with an investigational agent Uncontrolled seizure disorder or other serious neurologic disease ≥ Grade Ш allergic reaction to any drug including in this study Clinically significant cardiac or respiratory disease Creatinine clearance < 30ml/min Drug or alcohol addition Do not have full capacity for civil acts Severe complication, active infection Concurrent immunotherapy or hormone therapy for other diseases Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF+ Nimotuzumab<br>Patients treated with cisplatin and 5-Fu combined with nimotuzumab | Drug: cisplatin and 5-Fu combined with nimotuzumab<br>* DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks. Nimotuzumab 200mg/d, intravenous infusion every week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | To be determined by measurement of target lesions according to RECIST criteria | study period of 19 Months | 
| Progression free survival | Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause. | 19 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit. | 19 Months | 
| Quality of life | Using EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 2 cycles of chemotherapy, 1 months after all treatment finished. | 8 Months |