The present study will be a randomized, control, multicenter phase II study of metastatic nasopharyngeal carcinoma (NPC) treated with evacizumab (AVASTIN,Roch) with paclitaxel and carboplatin regimen (TC+AVASTIN) or carboplatin/paclitaxel alone (TC). The population consists of metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to RECIST 1.1 and NCI-CTC AE V4.0.TEORTC QLQ-C30 and EORTC QLQ-H\&N35 are used to measure PRO outcome for this study.
Nasopharyngeal carcinoma is vastly more common in East Asia, especially China has a high incidence of it, and the number of new cases will account for more than 40% of the world total . The disease involved population maybe more than 4 million in the world. More than 2700-3000 new nasopharyngeal carcinoma patients will be diagnosed in SUN YAT-SEN university cancer center every year. It is most common in 40-50 years old adults and has been a top ten (10th) malignant tumor in Chinese male which threaten human health and social economy. Chemotherapy is the standard treatment of the advanced nasopharyngeal carcinoma.Several other phase II study also confirmed the effectiveness of paclitaxel and carboplatin (TC) regimen in advanced NPC, so it maybe a simple right choice. Increasing expression of VEGF in serum associated with poor prognosis in metastatic nasopharyngeal carcinoma. Agents that selectively target VEGF-A and its receptors have shown significant antitumor effects in xenograft models of nasopharyngeal. Studies demonstrated that bevacizumab(AVASTIN) administration with chemotherapy or chemoradiation is feasible in patients with nasopharyngeal cancer. Bevacizumab can be safely combined with a range of cytotoxic and other anticancer agents including TC regimen. Evidence indicated a potential possibility that the TC+AVASTIN regimen may be superior than TC regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle
Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle
Carboplatin AUC 6 IV Day 1 each 3-week cycle
Dongguan People's Hospital
Dongguan, Guangdong, China
RECRUITINGDepartment of Medical Oncology,Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGFirst Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGGuangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
RECRUITINGShenzhen People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
RECRUITINGHainan General Hospital
Haikou, Hainan, China
RECRUITINGProgression free survival(PFS)
Time frame: 3 years
Overall survival(OS)
Time frame: 3 years
Overall response rate (ORR,CR+PR)
Identified by investigators and independent radiologic review (IRC) respectively
Time frame: 3 years
Disease control rate(DCR,CR+PR+SD)
Identified by investigators and IRC respectively
Time frame: 3 years
Health-related quality of life
Time frame: 3 years
Number of Participants with Adverse Events
Time frame: 3 years
Progression free survival(PFS)
Identified by IRC
Time frame: 3 years
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