Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: endostatin

• Registration Number: NCT01612286
• Lead Sponsor: Zhejiang Cancer Hospital

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).

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-28
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Status Verified: 2013-04
• Primary Completion: 2013-12
• Last Update Submitted: 2014-02-16
• Last Update Posted: 2014-02-19
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endostatin	endostatin	chemotherapy concurrently with endostatin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Zhejiang cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China