Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01612286

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: endostatin	Phase 2

Detailed Description

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endostatin chemotherapy concurrently with endostatin	Drug: endostatin Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles Other Names: endostar

Arm

Intervention/Treatment

Experimental: endostatin

chemotherapy concurrently with endostatin

Drug: endostatin

Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles

Other Names:

endostar

Outcome Measures

Primary Outcome Measures

progress free survival(PFS) [1 year and 2years]
PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates

Secondary Outcome Measures

overall survival(OS) [baseline to date of death from any cause]
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
Adverse events [participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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