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Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Zhejiang Cancer Hospital.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Zhejiang Cancer Hospital Identifier:
First received: May 28, 2012
Last updated: February 16, 2014
Last verified: April 2013
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 Intervention Phase
Nasopharyngeal Carcinoma Drug: endostatin Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • progress free survival(PFS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: endostatin
chemotherapy concurrently with endostatin
Drug: endostatin
Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles
Other Name: endostar

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).

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01612286

China, Zhejiang
Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Principal Investigator: Bin Li Zhejiang Cancer Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Zhejiang Cancer Hospital Identifier: NCT01612286     History of Changes
Other Study ID Numbers: ZhejaingCH-npc-02
Study First Received: May 28, 2012
Last Updated: February 16, 2014

Keywords provided by Zhejiang Cancer Hospital:
Recombinant human endostatin
nasopharyngeal carcinoma

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on September 18, 2017