Clinical trial NCT01616849: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage IV Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fujian Cancer Hospital
name: First People's Hospital of Foshan
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Guangxi Medical University
name: Guangzhou Medical University
name: Hubei Cancer Hospital
name: Hunan Provincial Cancer Hospital
name: Hangzhou Cancer Hospital
name: Wuhan Union Hospital, China
name: Tongji Hospital
name: Jiangxi Provincial Cancer Hospital
name: Affiliated Cancer Hospital of Shantou University Medical College
name: Wuhan University
name: Zhejiang Cancer Hospital
First posted: 2012-06-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Objective response rate
timeFrame: study period of 19 Months
measure: Progression free survival
timeFrame: 19 Months
Secondary outcomes:
measure: Overall survival
timeFrame: 19 Months
measure: Quality of life
timeFrame: 8 Months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.