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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00096512
First received: November 9, 2004
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
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
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of BAY 43-9006 (NSC-724772) in Patients With Recurrent or Metastatic Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 3 years ] [ Designated as safety issue: No ]
    A 95% confidence interval will be provided.

  • Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    A 95% confidence interval will be provided.

  • Toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    A 95% confidence interval will be provided.

  • Effects of the agent on the Ras signal transduction pathway [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2004
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Given orally
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the response probability (confirmed, complete and partial responses) in patients with metastatic head and neck cancer who are treated with BAY 43-9006.

II. To evaluate median progression-free survival and median overall survival. III. To evaluate the qualitative and quantitative toxicities of this regimen. IV. To investigate in a preliminary manner the effects of the agent on the Ras signal transduction pathway in tissue samples obtained prior to and after treatment.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3.3-8 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096512

Locations
United States, Texas
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
Investigators
Principal Investigator: Stephen Williamson Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096512     History of Changes
Other Study ID Numbers: NCI-2012-03043, S0420, U10CA032102, CDR0000393212
Study First Received: November 9, 2004
Last Updated: February 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Laryngeal Diseases
Tongue Neoplasms
Carcinoma, Verrucous
Neoplasms, Unknown Primary
Salivary Gland Neoplasms
Hypopharyngeal Neoplasms
Laryngeal Neoplasms
Paranasal Sinus Neoplasms
Oropharyngeal Neoplasms
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Salivary Gland Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014