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New combo therapy shows promise for tough head and neck cancers

NCT ID NCT00939627

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tested whether adding sorafenib to cetuximab works better than cetuximab alone for patients with advanced head and neck cancer that has come back or spread. Fifty-five adults with various types of head and neck cancer took part. The study measured how long patients lived without their cancer getting worse and how their tumors responded to treatment.

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 it works, this could point toward a more effective treatment option for patients with advanced head and neck cancer who have not responded to prior therapies.
What could go wrong
This is a small, early-phase trial (55 participants) that may not show a clear benefit. The combination could also cause more side effects than cetuximab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Start date

Jul 2009

Finished

Jan 2014

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with recurrent, refractory or metastatic squamous cell carcinoma of oral cavity, oropharynx and larynx, hypopharynx or paranasal sinus, head and neck unknown primary or nasopharyngeal carcinoma WHO type 1; patients with recurrent, refractory or metastatic squamous cell carcinoma of oral cavity, oropharynx and larynx, hypopharynx or paranasal sinus, head and neck unknown primary or nasopharyngeal carcinoma WHO type 1; patients may have had up to 1 prior palliative chemotherapy for recurrent or metastatic disease; please note that chemotherapy given as part of a regimen for curative intent for recurrent disease does not count as "prior chemotherapy;" patients must not presently be candidates for curative therapy * ECOG performance status 0, 1 or 2 * Hemoglobin \>= 9.0/dl * Absolute-neutrophil count (ANC) \>= 1500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Total bilirubin =\< 1.5 x ULN * ALT and AST =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement) * INR \< 1.5 or a PT and PTT within normal limits * Creatinine =\< 1.5 x ULN * If primary therapy was given for curative intent, at least 4 weeks must have elapsed after completion of primary therapy prior to enrollment on this clinical trial; however, toxicities from prior treatment must have resolved to grade 1 or less * Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of the treatment; women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation (i.e, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for a minimum of 3 months following the last dose of chemotherapy; male subject agrees to use an acceptable method for contraception for the duration of the study and for a minimum of 3 months following the last dose of chemotherapy * Patients must have a measurable disease defined by RECIST criteria * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care; patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial Exclusion Criteria: * Prior treatment with sorafenib or cetuximab * Patients with active clinically significant infection or with a fever \>= 38.5º C within 3 days of the first scheduled day of protocol treatment * History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma and squamous cell carcinoma of the skin, CIN or localized prostate cancer with a current PSA \< 1.0 mg/dL on 2 successive evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of study entry * Patients with known hypersensitivity to sorafenib or cetuximab * Prior severe infusion reaction to a monoclonal antibody * History of hand-foot syndrome * Pregnant or lactating; sexually active women of childbearing potential must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized * Known untreated brain metastasis; patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis or progression of brain metastasis; patients with treated brain metastasis are eligible for study as long as no evidence of progression of CNS disease; hemorrhagic brain metastases are not allowed on study * Uncontrolled comorbid illness * Patients with HIV who are taking antiretroviral mediations will be excluded because of the potential interactions of anti-retroviral medications with these agent; however, given the potential immune modulating effects of sorafenib, investigators should still be very cautious about placing HIV positive patients on this trial as the effects of these medications on the HIV virus itself are not know * History of allogeneic transplant * Patient has received other investigational drugs within 28 days before enrollment * Cardiac disease: congestive heart failure \> class II NYHA; patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months; significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension (defined as defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction will also be excluded from study; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy will also be excluded from study * Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months * Pulmonary hemorrhage/bleeding event \> CTCAE grade 2 within 4 weeks of first dose of study drug * Any other hemorrhage/bleeding event \> CTCAE grade 3 within 4 weeks of first dose of study drug * Tumor that invades the carotid artery as shown unequivocally by imaging studies * Serious non-healing wound, ulcer, or bone fracture * Evidence or history of bleeding diathesis or coagulopathy * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug * Use of St. John's Wort or rifampin (rifampicin) * Use of the following medications will not be allowed within 4 weeks prior to enrollment on the study and during the study: ketoconazole, itraconazole, ritonavir, cyclosporine, carbamazepine, phenytoin, phenobarbital; products containing grapefruit juice will not be allowed while on study * Known or suspected allergy to sorafenib or any agent given in the course of this trial * Any malabsorption problem * Known HIV positive patients will be excluded from trial due to the potential immune modulation that these agents may cause

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Conditions

The condition(s) this trial relates to.

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 nasopharynx Stage IVA salivary gland cancer 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 oropharynx 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 oral cavity Stage IVB salivary gland cancer 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 oropharynx 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 oral cavity Stage IVC salivary gland cancer 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 oropharynx 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 oral cavity Tongue cancer Untreated metastatic squamous neck cancer with occult primary

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.