CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
cetuximab +1 morebiological
Likely dose
cetuximab 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00661427
NCT00661427Phase 2Completed
CompareCT.gov

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.

Memorial Sloan Kettering Cancer Center·interventional·Posted Apr 18, 2008·Updated Jan 11, 2018

In Brief

A Phase 2 clinical trial evaluating cetuximab for Head and Neck and Squamous Cell Cancer. Completed, enrolled 61 participants across 17 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck, Squamous Cell Cancer
CountriesUnited States
CollaboratorsEli Lilly and Company, National Comprehensive Cancer Network

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2008
Enrollment StartNov 1, 2007
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.2 years ago

Interventions

cetuximabbiological

Cetuximab 500 mg/m\^2 IV over 2 hours every other week

cetuximabbiological

Cetuximab 750 mg/m\^2 IV over 3 hours every other week