S0420, Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Completed · Phase 2

Conditions studied: 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

In brief

Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cance

Key facts

Study ID: NCT00096512
Run by: National Cancer Institute (NCI)
People needed: 40
Starts: 2004-10-01
Last updated by the study team: 2013-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically proven squamous cell carcinoma of the head and neck region that is either metastatic at diagnosis or has persisted, metastasized or recurred following definitive surgery and/or radiation therapy and is not amenable to salvage surgical resection; selected patients who have relapsed following prior induction or adjuvant therapy are eligible; patients with newly diagnosed non-metastatic disease are not eligible
Patients must be willing to submit archived tissue specimens for immunohistochemistry correlative studies; the tissue can be from either the primary or metastatic site
Patients must not have received prior chemotherapy for the recurrent or newly diagnosed metastatic disease; patients who have received induction or adjuvant chemotherapy are eligible, provided that at least six months have elapsed since the last course of chemotherapy was administered; patients may have received only one induction or adjuvant regimen
Prior radiation must have been completed at least 28 days prior to registration and all toxicities must have been resolved
Surgery must have been completed at least 28 days prior to registration and all complications/adverse events must have been resolved
Patients must have measurable disease; all measurable disease must be assessed within 28 days prior to registration; if the patient also has non-measurable disease, then non-measurable disease must be assessed within 42 days prior to registration; patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration
Patients must not be planning to receive any other concurrent therapy (i.e. radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) for squamous cell carcinoma of the head and neck (SCCHN) while they are on this study
Patients must have a Zubrod performance status of 0 or 1
Patients with active infection requiring systemic therapy are not eligible
Patients with active or prior central nervous system (CNS) metastasis are not eligible
Granulocyte count > 1,500/mm\^3
Platelet count > 100,000/mm\^3
Serum creatinine < 2 x the institutional upper limit of normal
Bilirubin =< 2 x the institutional upper limit of normal
Alkaline phosphatase =< 2 x the institutional upper limit of normal
SGOT or SGPT =< 2 x the institutional upper limit of normal
Patients must not have psychological, familial, sociological, or geographical conditions that prevent medical follow-up and compliance with the protocol treatment
Patients must not have a significant history of cardiac disease, e.g., uncontrolled hypertension, unstable angina, congestive-heart failure, and myocardial infarction within the last six months, or cardiac ventricular arrhythmias requiring medication
Patients must either be able to take oral medication without crushing, dissolving or chewing tablets
Patients must not have any evidence of bleeding diathesis
Patients must not be on therapeutic anticoagulation
No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years
Pregnant or nursing women may not participate in this trial; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Where it is running

Southwest Oncology Group (SWOG) Research Base — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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