Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Fujian Cancer Hospital
First People's Hospital of Foshan
People's Hospital of Guangxi
Guangxi Medical University
Guangzhou Medical University
Hubei Cancer Hospital
Hunan Provincial Cancer Hospital
Hangzhou Cancer Hospital
Wuhan Union Hospital, China
Tongji Hospital
Jiangxi Provincial Cancer Hospital
Cancer Hospital of Shantou University
Wuhan University
Zhejiang Cancer Hospital
Information provided by (Responsible Party):
Zhao Chong, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01616849
First received: May 20, 2012
Last updated: September 19, 2015
Last verified: September 2015
  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:


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.


Enrollment: 39
Study Start Date: May 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Adult, Senior)
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
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: NCT01616849

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Fujian Cancer Hospital
First People's Hospital of Foshan
People's Hospital of Guangxi
Guangxi Medical University
Guangzhou Medical University
Hubei Cancer Hospital
Hunan Provincial Cancer Hospital
Hangzhou Cancer Hospital
Wuhan Union Hospital, China
Tongji Hospital
Jiangxi Provincial Cancer Hospital
Cancer Hospital of Shantou University
Wuhan University
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Chong Zhao, MD Sun Yat-sen University
  More Information

Additional Information:
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: September 19, 2015
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
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2016