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New combo therapy shows promise for tough head and neck cancers

NCT ID NCT00939627

First seen Mar 17, 2026 · Last updated Jun 22, 2026 · Updated 16 times

Summary

This phase 2 trial tested whether adding sorafenib to the standard drug cetuximab works better than cetuximab alone for people with advanced head and neck cancer that has come back or spread. Fifty-five patients were randomly assigned to one of the two treatments. The main goal was to see how long patients lived without their cancer getting worse.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • Billings Clinic

    Billings, Montana, 59107-7000, United States

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490, United States

  • Suburban Hospital

    Bethesda, Maryland, 20814, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

cetuximab and sorafenib tosylate

What this could lead to

If successful, this could point toward a new combination treatment option for patients with advanced head and neck cancer that has not responded to prior therapies.

What could go wrong

This is a small, early-phase trial with only 55 participants. The combination may not improve survival or could cause added side effects like fatigue, rash, or high blood pressure.

Conditions

The condition(s) this trial relates to.

salivary gland cancer Squamous Cell Carcinoma of Head and Neck tongue cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC SQUAMOUS NECK CANCER WITH OCCULT PRIMARY SQUAMOUS CELL CARCINOMA RECURRENT METASTATIC SQUAMOUS NECK CANCER WITH OCCULT PRIMARY RECURRENT SALIVARY GLAND CANCER RECURRENT SQUAMOUS CELL CARCINOMA OF THE HYPOPHARYNX RECURRENT SQUAMOUS CELL CARCINOMA OF THE LARYNX RECURRENT SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY RECURRENT SQUAMOUS CELL CARCINOMA OF THE NASOPHARYNX RECURRENT SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX RECURRENT SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY RECURRENT VERRUCOUS CARCINOMA OF THE LARYNX RECURRENT VERRUCOUS CARCINOMA OF THE ORAL CAVITY SALIVARY GLAND SQUAMOUS CELL CARCINOMA STAGE IV SQUAMOUS CELL CARCINOMA OF THE HYPOPHARYNX STAGE IV SQUAMOUS CELL CARCINOMA OF THE HYPOPHARYNX STAGE IV SQUAMOUS CELL CARCINOMA OF THE NASOPHARYNX STAGE IV SQUAMOUS CELL CARCINOMA OF THE NASOPHARYNX STAGE IVA SALIVARY GLAND CANCER STAGE IVA SALIVARY GLAND CANCER STAGE IVA SQUAMOUS CELL CARCINOMA OF THE LARYNX STAGE IVA SQUAMOUS CELL CARCINOMA OF THE LARYNX STAGE IVA SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY STAGE IVA SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY STAGE IVA SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX STAGE IVA SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX STAGE IVA SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY STAGE IVA SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY STAGE IVA VERRUCOUS CARCINOMA OF THE LARYNX STAGE IVA VERRUCOUS CARCINOMA OF THE LARYNX STAGE IVA VERRUCOUS CARCINOMA OF THE ORAL CAVITY STAGE IVA VERRUCOUS CARCINOMA OF THE ORAL CAVITY STAGE IVB SALIVARY GLAND CANCER STAGE IVB SALIVARY GLAND CANCER STAGE IVB SQUAMOUS CELL CARCINOMA OF THE LARYNX STAGE IVB SQUAMOUS CELL CARCINOMA OF THE LARYNX STAGE IVB SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY STAGE IVB SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY STAGE IVB SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX STAGE IVB SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX STAGE IVB SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY STAGE IVB SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY STAGE IVB VERRUCOUS CARCINOMA OF THE LARYNX STAGE IVB VERRUCOUS CARCINOMA OF THE LARYNX STAGE IVB VERRUCOUS CARCINOMA OF THE ORAL CAVITY STAGE IVB VERRUCOUS CARCINOMA OF THE ORAL CAVITY STAGE IVC SALIVARY GLAND CANCER STAGE IVC SALIVARY GLAND CANCER STAGE IVC SQUAMOUS CELL CARCINOMA OF THE LARYNX STAGE IVC SQUAMOUS CELL CARCINOMA OF THE LARYNX STAGE IVC SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY STAGE IVC SQUAMOUS CELL CARCINOMA OF THE LIP AND ORAL CAVITY STAGE IVC SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX STAGE IVC SQUAMOUS CELL CARCINOMA OF THE OROPHARYNX STAGE IVC SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY STAGE IVC SQUAMOUS CELL CARCINOMA OF THE PARANASAL SINUS AND NASAL CAVITY STAGE IVC VERRUCOUS CARCINOMA OF THE LARYNX STAGE IVC VERRUCOUS CARCINOMA OF THE LARYNX STAGE IVC VERRUCOUS CARCINOMA OF THE ORAL CAVITY STAGE IVC VERRUCOUS CARCINOMA OF THE ORAL CAVITY TONGUE CANCER UNTREATED METASTATIC SQUAMOUS NECK CANCER WITH OCCULT PRIMARY