Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab

ClinicalTrials.gov ID: NCT00939627

Public ClinicalTrials.gov record NCT00939627. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 11, 2026, 5:28 PM EDT

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Official title

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab in Patients With Refractory, Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether cetuximab is more effective when given alone or together with sorafenib tosylate in treating patients with head and neck cancer. This randomized phase II trial is studying cetuximab to see how well it works when given together with or without sorafenib tosylate in treating patients with refractory, recurrent, and/or metastatic head and neck cancer.

Study identification

NCT ID: NCT00939627
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 55 participants

Conditions and interventions

Conditions

Interventions

Biological · Other · Drug + 1 more

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 30, 2009
Primary completion: Dec 31, 2012
Completion: Dec 31, 2013
Last update posted: Mar 9, 2026

2009 – 2014

United States locations

U.S. sites: 8
U.S. states: 7
U.S. cities: 8

Facility	City	State	ZIP	Site status
H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	33612	—
Emory University/Winship Cancer Institute	Atlanta	Georgia	30322	—
Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland	21287	—
Suburban Hospital	Bethesda	Maryland	20814	—
Billings Clinic	Billings	Montana	59107-7000	—
Montefiore Medical Center	The Bronx	New York	10467-2490	—
University of North Carolina	Chapel Hill	North Carolina	27599	—
Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	37232	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00939627, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 9, 2026 · Synced Sep 11, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00939627 live on ClinicalTrials.gov.

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