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Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT01612286
Recruitment Status : Unknown
Verified April 2013 by Zhejiang Cancer Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2012
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 2012
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: endostar


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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


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

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612286


Locations
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China, Zhejiang
Zhejiang cancer hospital
Hangzhou, Zhejiang, China, 310022
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: Bin Li Zhejiang Cancer Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01612286    
Other Study ID Numbers: ZhejaingCH-npc-02
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: April 2013
Keywords provided by Zhejiang Cancer Hospital:
Recombinant human endostatin
nasopharyngeal carcinoma
chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
 Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents