NCT00661427

Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer

A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m^2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.

Conditions

• Head and Neck
• Squamous Cell Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	Cetuximab 500 mg/m\^2 IV over 2 hours every other week
BIOLOGICAL	cetuximab	Cetuximab 750 mg/m\^2 IV over 3 hours every other week

Timeline

• Start date: 2007-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-04-18
• Last updated: 2018-01-11
• Results posted: 2015-11-20

Locations

17 sites across 1 country: United States