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Clinical trialNCT00939627CompletedPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment55Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral Cavity+31 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, United States

  • Emory University/winship Cancer Institute

    Atlanta, Georgia, United States

  • Johns Hopkins University/sidney Kimmel Cancer Center

    Baltimore, Maryland, United States

  • Suburban Hospital

    Bethesda, Maryland, United States

  • Billings Clinic

    Billings, Montana, United States

  • Montefiore Medical Center

    The Bronx, New York, United States

  • University of North Carolina

    Chapel Hill, North Carolina, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2009
Primary completion
31 Jan 2013
Completion
31 Jan 2014
Last update posted
10 Mar 2026
Registered enrollment
55
Registry id
NCT00939627

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.