CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Cetuximab +5 moredrug
Likely dose
Cetuximab 250mg/m2from 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/NCT00468169
NCT00468169Phase 2Completed
CompareCT.gov

A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer

University of Chicago·interventional·Posted May 2, 2007·Updated Oct 9, 2019

In Brief

A Phase 2 clinical trial evaluating Cetuximab, 5-FU, and 4 other interventions for Head and Neck Cancer. Completed, enrolled 110 participants across 1 site.

Detailed Summary

The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2, 2007
Enrollment StartJul 1, 2006
Primary CompletionAug 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 19.2 years ago

Interventions

Cetuximabdrug

250mg/m2(day 1, weekly x 10);

5-FUdrug

600 mg/m2/day; days 0-5 (120 h total) every other week x 5

Hydroxyureadrug

500 mg PO BID, days 0-5 every other week x 5

Twice-daily radiationradiation

150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)

Cisplatindrug

100 mg/m2, week 1 and 4 on day 1 (or 2)

Accelerated fraction radiotherapy with concomitant boostradiation

72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.