Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
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|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|
|Actual Primary Completion Date :||July 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|