drugset / Trial / NCT00747799

Study of Combination of Sorafenib With Cisplatin and 5-fluorouracil as First-line Treatment of Recurrence After Radiotherapy Patients Who Failed With Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

NCT00747799 ↗

Phase 2 Completed 54 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

This study is a phase II clinical study. Recurrence after radiotherapy patients who are failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective response(complete response (CR) + partial response (PR)), Disease Control Rate , safety profile, tolerability will be evaluated according to World Health Organization (WHO) criteria.

Timeline

Start
2009-01
Primary completion
2011-05
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 80 mg/m2 —
Subject Sorafenib Small molecule 400 mg —
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous