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Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

This study is currently recruiting participants.
Verified March 2012 by Sun Yat-sen University
Sponsor:
Collaborators:
Fujian Provincial Cancer Hospital
First People's Hospital of Foshan
The People's Hospital of Guangxi Zhuang Autonomous Region
Guangxi Medical University
Guangzhou Medical University
Hubei Provincial Cancer Hospital
Hunan Provincial Cancer Hospital
Hangzhou Cancer hospital
Union Hospital Of Huazhong University of Science & Technology
Tongji Hospital Of Huazhong University of Science & Technology
Jiangxi Provincial Cancer Hospital
Cancer Hospital of Shantou University
Wuhan University
Zhejiang Provincial Cancer Hospital
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01616849
First received: May 20, 2012
Last updated: June 8, 2012
Last verified: March 2012
History of Changes
  Purpose

This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.


Condition Intervention Phase
Stage IV Nasopharyngeal Carcinoma
 Drug: cisplatin and 5-Fu combined with nimotuzumab
 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: Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: study period of 19 Months ] [ Designated as safety issue: No ]
    To be determined by measurement of target lesions according to RECIST criteria

  • Progression free survival [ Time Frame: 19 Months ] [ Designated as safety issue: No ]
    Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 19 Months ] [ Designated as safety issue: No ]
    Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit.

  • Quality of life [ Time Frame: 8 Months ] [ Designated as safety issue: Yes ]
    Using EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 2 cycles of chemotherapy, 1 months after all treatment finished.


Estimated Enrollment: 39
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF+ Nimotuzumab
Patients treated with cisplatin and 5-Fu combined with nimotuzumab
 Drug: cisplatin and 5-Fu combined with nimotuzumab

DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks.

Nimotuzumab 200mg/d, intravenous infusion every week

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of nasopharyngeal carcinoma
  • Distance metastasis at least 6 months after radical treatment
  • Not suitable for local treatment, e.g. surgery, TACE
  • At least one measurable lesion
  • Estimate survival ＞3months
  • Range from 18～70 years old
  • PS 0~1
  • WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
  • ALT or AST ＜ 2.5×ULN、bilirubin ＜ 1.5×ULN
  • 0Serum creatinine ＜ 1.5×ULN

Exclusion Criteria:

  • Central nervous system metastases
  • Suitable for local treatment
  • Second malignancy within 5 years
  • Precious therapy with an investigational agent
  • Uncontrolled seizure disorder or other serious neurologic disease
  • ≥ Grade Ш allergic reaction to any drug including in this study
  • Clinically significant cardiac or respiratory disease
  • Creatinine clearance < 30ml/min
  • Drug or alcohol addition
  • Do not have full capacity for civil acts
  • Severe complication, active infection
  • Concurrent immunotherapy or hormone therapy for other diseases
  • Pregnancy or lactation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616849

Contacts
Contact: Shen Guanzhu 86-13427529949 shenguanzhu@gmail.com

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Chong Zhao     +86-13902206160     zhaochong@sysucc.org.cn    
Sponsors and Collaborators
Sun Yat-sen University
Fujian Provincial Cancer Hospital
First People's Hospital of Foshan
The People's Hospital of Guangxi Zhuang Autonomous Region
Guangxi Medical University
Guangzhou Medical University
Hubei Provincial Cancer Hospital
Hunan Provincial Cancer Hospital
Hangzhou Cancer hospital
Union Hospital Of Huazhong University of Science & Technology
Tongji Hospital Of Huazhong University of Science & Technology
Jiangxi Provincial Cancer Hospital
Cancer Hospital of Shantou University
Wuhan University
Zhejiang Provincial Cancer Hospital
Investigators
Principal Investigator: Chong Zhao, MD Sun Yat-sen University
  More Information

Additional Information:
Home Page of Cancer Center, Sun Yat-sen University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Zhao Chong, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01616849     History of Changes
Other Study ID Numbers: PF-N-UMNPC
Study First Received: May 20, 2012
Last Updated: June 8, 2012
Health Authority: China: Ethics Committee

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
 Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013