Nasopharyngeal Neoplasms Clinical Trial
Official title:
Multi-center, Randomized, Controlled, Open-label Study of Bevacizumab With Carboplatin and Paclitaxel Versus Carboplatin and Paclitaxel in Patients With Metastatic Nasopharyngeal Carcinoma
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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