Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

Stage IV Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616849
• Other study ID #: PF-N-UMNPC
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2012
• Last updated: September 19, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 ? 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Neoplasms
• Stage IV Nasopharyngeal Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (15)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Hospital of Shantou University, First People's Hospital of Foshan, Fujian Cancer Hospital, Guangxi Medical University, Guangzhou Medical University, Hangzhou Cancer Hospital, Hubei Cancer Hospital, Hunan Provincial Cancer Hospital, Jiangxi Provincial Cancer Hospital, People's Hospital of Guangxi, Tongji Hospital, Wuhan Union Hospital, China, Wuhan University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	To be determined by measurement of target lesions according to RECIST criteria	study period of 19 Months	No
Primary	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.	19 Months	No
Secondary	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.	19 Months	No
Secondary	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.	8 Months	Yes

External Links

•   Home Page of Cancer Center, Sun Yat-sen University