Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01612286
• Other study ID #: ZhejaingCH-npc-02
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 28, 2012
• Last updated: February 16, 2014
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2013
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang cancer hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes