Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01612286
First received: May 28, 2012
Last updated: February 16, 2014
Last verified: April 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612286

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

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01612286     History of Changes
Other Study ID Numbers: ZhejaingCH-npc-02
Study First Received: May 28, 2012
Last Updated: February 16, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Endostatins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014