drugset / Trial / NCT02250599

Efficacy and Safety of TC+AVASTIN Versus TC in Patients With Metastatic Nasopharyngeal Carcinoma

NCT02250599 ↗

Phase 2 Unknown 80 enrolled Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-08
Primary completion
2016-04
Completion
2016-12

Outcome

Missed primary endpoint

paper CONCLUSIONS: Addition of bevacizumab to paclitaxel plus carboplatin as first-line treatment did not prolong PFS and OS in patients with R/M NPC PMID 34837744 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous