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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612286
First Posted: June 5, 2012
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
May 28, 2012
June 5, 2012
February 19, 2014
May 2012
December 2013   (Final data collection date for primary outcome measure)
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
1-year progress free survival(PFS) [ Time Frame: 1 year after the inception assignment ]
PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates
Complete list of historical versions of study NCT01612286 on ClinicalTrials.gov Archive Site
  • 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
  • overall survival(OS) [ Time Frame: 1 year ,2 years and 3 years after the inception of the assignment ]
    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
Not Provided
Not Provided
 
Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma
A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma
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).
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).
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nasopharyngeal Carcinoma
Drug: endostatin
Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles
Other Name: endostar
Experimental: endostatin
chemotherapy concurrently with endostatin
Intervention: Drug: endostatin
Jin T, Li B, Chen XZ. A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286). Oncol Res. 2013;21(6):317-23. doi: 10.3727/096504014X13983417587401.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
May 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01612286
ZhejaingCH-npc-02
Yes
Not Provided
Not Provided
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
Not Provided
Principal Investigator: Bin Li Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP