CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Cetuximab +1 moredrug
Likely dose
Cetuximab 400 mg/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/NCT00409565
NCT00409565Phase 2Completed
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A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer

National Cancer Institute (NCI)·interventional·Posted Dec 11, 2006·Updated Oct 20, 2017

In Brief

A Phase 2 clinical trial evaluating Cetuximab and Bevacizumab for Head and Neck Cancer and Squamous Cell Carcinoma. Completed, enrolled 48 participants across 4 sites.

Detailed Summary

The purpose of this study is to determine if the combination of two new drugs, cetuximab (Erbitux) and bevacizumab (Avastin) can increase the effectiveness of treatment for head and neck cancer. Cetuximab has recently been approved by the FDA for head and neck cancer (that is locally or regionally advanced) when used in combination with radiation therapy. Cetuximab is also approved by the FDA for the treatment of colorectal cancer

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Squamous Cell Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2006
Enrollment StartSep 1, 2006
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 19.6 years ago

Interventions

Cetuximabdrug

* Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY * Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations

Bevacizumabdrug

Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given