Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
|ClinicalTrials.gov Identifier: NCT01616849|
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : September 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Nasopharyngeal Carcinoma||Drug: cisplatin and 5-Fu combined with nimotuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2012|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
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
- Objective response rate [ Time Frame: study period of 19 Months ]To be determined by measurement of target lesions according to RECIST criteria
- Progression free survival [ Time Frame: 19 Months ]Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.
- Overall survival [ Time Frame: 19 Months ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616849
|Cancer Center, Sun Yat-sen University|
|Guangzhou, Guangdong, China|
|Principal Investigator:||Chong Zhao, MD||Sun Yat-sen University|