Back to resultsStudy of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
Primary Purpose
Stage IV Nasopharyngeal Carcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cisplatin and 5-Fu combined with nimotuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Nasopharyngeal Carcinoma
Eligibility 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
Sites / Locations
- Cancer Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PF+ Nimotuzumab
Arm Description
Patients treated with cisplatin and 5-Fu combined with nimotuzumab
Outcomes
Primary Outcome Measures
Objective response rate
To be determined by measurement of target lesions according to RECIST criteria
Progression free survival
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
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
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.
Full Information
NCT ID
NCT01616849
First Posted
May 20, 2012
Last Updated
September 19, 2015
Sponsor
Sun Yat-sen University
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, Affiliated Cancer Hospital of Shantou University Medical College, Wuhan University, Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01616849
Brief Title
Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
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, Affiliated Cancer Hospital of Shantou University Medical College, Wuhan University, Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF+ Nimotuzumab
Arm Type
Experimental
Arm Description
Patients treated with cisplatin and 5-Fu combined with nimotuzumab
Intervention Type
Drug
Intervention Name(s)
cisplatin and 5-Fu combined with nimotuzumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Objective response rate
Description
To be determined by measurement of target lesions according to RECIST criteria
Time Frame
study period of 19 Months
Title
Progression free survival
Description
Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.
Time Frame
19 Months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit.
Time Frame
19 Months
Title
Quality of life
Description
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.
Time Frame
8 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong Zhao, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30689735
Citation
Zhao C, Miao J, Shen G, Li J, Shi M, Zhang N, Hu G, Chen X, Hu X, Wu S, Chen J, Shao X, Wang L, Han F, Mai H, Chua MLK, Xie C. Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with cisplatin and 5-fluorouracil in patients with metastatic nasopharyngeal carcinoma after radical radiotherapy: a multicentre, open-label, phase II clinical trial. Ann Oncol. 2019 Apr 1;30(4):637-643. doi: 10.1093/annonc/mdz020.
Results Reference
derived
Links:
URL
http://www.sysucc.org.cn
Description
Home Page of Cancer Center, Sun Yat-sen University
Learn more about this trial
Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
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