Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Detailed Description
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To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).

Official Title
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A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed metastatic NPC patient who have received radiotherapy or chemoradiotherapy with an at least 6 months interval Have measurable lesions No dysfunction of the major organs Can understand this study and give a signed informed consent certificates without a history of allergic reaction to the biological agents Exclusion Criteria: Pregnant or lactating women; Women of child-bearing age without contraception with a Serious infection or dysfunction of the major organs have taken other antitumor drugs during the period of 30 days ahead of this clinical trial allergic to the Escherichia coli preparations Cann't understand this study and give a signed informed consent certificates

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: endostatin<br>chemotherapy concurrently with endostatin | Drug: endostatin<br>* Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles<br>* Other names: endostar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress free survival(PFS) | PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates | 1 year and 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival(OS) | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to caculate the 1-year ,2-year,3-year overall survival rate | baseline to date of death from any cause | 
| Adverse events | observe and record the toxicity profile(incluing but not limit to mocositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edtion) during the chemotherapy,Targeted therapy and follow-up | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant human endostatin, nasopharyngeal carcinoma, chemotherapy