Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma
This study is currently recruiting participants.
Verified April 2013 by Zhejiang Cancer Hospital
Sponsor:
Zhejiang Cancer Hospital
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01612286
First received: May 28, 2012
Last updated: April 15, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612286
Contacts
| Contact: Bin Li | 86-571-88122091 | libindoctor@163.com |
Locations
| China, Zhejiang | |
| Zhejiang cancer hospital | Recruiting |
| Hangzhou, Zhejiang, China, 310022 | |
| Contact: Bin Li 86-571-88122091 libndoctor@163.com | |
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: | April 15, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang Cancer Hospital:
|
Recombinant human endostatin nasopharyngeal carcinoma chemotherapy |
Additional relevant MeSH terms:
|
Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Carcinoma 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 May 21, 2013