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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Neoplasms

Interventions

Type	Name	Description
DRUG	Sorafenib plus Cisplatin and 5-fluorouracil	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) * Sorafenib 400 mg bid per daily . Every 21-day cycles. * Cisplatin 80 mg/m2 day d1, every 21 days cycle. * 5-fluorouracil 1000 mg/m2 day CIV 4days, repeat 21-day cycles

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-05-01
• Completion: 2011-11-01
• First posted: 2008-09-05
• Last updated: 2013-12-10

Locations

1 site across 1 country: China