Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma

NCT01612286 | Unknown Phase 2 DMC

• 1 other identifier: ZhejaingCH-npc-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Nasopharyngeal Carcinoma

Keywords

Recombinant human endostatin; nasopharyngeal carcinoma; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

  1 year and 2years

Secondary Outcomes (2)

• overall survival(OS)

  baseline to date of death from any cause

• Adverse events

  participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year

Study Arms (1)

endostatin

EXPERIMENTAL

chemotherapy concurrently with endostatin

Drug: endostatin

Interventions

endostatin DRUG

Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle \*4cycles

Also known as: endostar

endostatin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• 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.

  PMID: 25198661 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endostatins; endostar protein

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors

Study Officials

• Bin Li

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: June 5, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: February 19, 2014

Record last verified: 2013-04

Locations

CN (1)