NCT01370876

Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Nang Kuang Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.

Detailed description

To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer. To assess the safety profile of these treatment regimen. To evaluate the duration of response of oxaliplatin/5-FU.

Conditions

• Cancer of the Head and Neck
• Neoplasms, Head and Neck

Interventions

Type	Name	Description
DRUG	Oxaliplatin	Oxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2012-05-01
• First posted: 2011-06-10
• Last updated: 2013-12-10

Locations

1 site across 1 country: Taiwan