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Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
endostatin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Recombinant human endostatin, nasopharyngeal carcinoma, chemotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endostatin

Arm Description

chemotherapy concurrently with endostatin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
May 28, 2012
Last Updated
February 16, 2014
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01612286
Brief Title
Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma
Official Title
A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Recombinant human endostatin, nasopharyngeal carcinoma, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endostatin
Arm Type
Experimental
Arm Description
chemotherapy concurrently with endostatin
Intervention Type
Drug
Intervention Name(s)
endostatin
Other Intervention Name(s)
endostar
Intervention Description
Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles
Primary Outcome Measure Information:
Title
progress free survival(PFS)
Description
PFS means assignament to the date of any local or distant progress of the disease useing Kaplan-Meier caculate the progress free survival rates
Time Frame
1 year and 2years
Secondary Outcome Measure Information:
Title
overall survival(OS)
Description
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
Time Frame
baseline to date of death from any cause
Title
Adverse events
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Li
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang cancer hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25198661
Citation
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.
Results Reference
derived

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Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

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