Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
NCT ID: NCT01616849
Last Updated: 2015-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
39 participants
INTERVENTIONAL
2012-05-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PF+ Nimotuzumab
Patients treated with cisplatin and 5-Fu combined with nimotuzumab
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
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
First People's Hospital of Foshan
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Guangxi Medical University
OTHER
Guangzhou Medical University
OTHER
Hubei Cancer Hospital
OTHER
Hunan Provincial Cancer Hospital
UNKNOWN
Hangzhou Cancer Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Tongji Hospital
OTHER
Jiangxi Provincial Cancer Hospital
OTHER
Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Wuhan University
OTHER
Zhejiang Cancer Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Zhao Chong
MD
Principal Investigators
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Chong Zhao, MD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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References
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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.
Related Links
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Home Page of Cancer Center, Sun Yat-sen University
Other Identifiers
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PF-N-UMNPC
Identifier Type: -
Identifier Source: org_study_id
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