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Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
This study is ongoing, but not recruiting participants.
First Received: November 9, 2004   Last Updated: July 23, 2008   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096512
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: sorafenib tosylate
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
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):

Study Start Date: October 2004
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate (confirmed, complete and partial responses) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with sorafenib.
  • Determine the median progression-free survival and median overall survival of patients treated with this drug.

Secondary

  • Determine the qualitative and quantitative toxic effects of this drug in these patients.

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following criteria:

    • Metastatic at diagnosis
    • Persistent, recurrent, or metastatic disease after definitive surgery and/or radiotherapy
    • Relapsed disease after prior induction or adjuvant therapy
  • Not amenable to salvage surgical resection
  • No newly diagnosed nonmetastatic disease
  • Measurable disease

    • If only site of measurable disease is within a prior radiotherapy port, then clearly progressive disease must be demonstrated
  • No prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2 times ULN
  • SGOT or SGPT ≤ 2 times ULN

Renal

  • Creatinine < 2 times ULN

Cardiovascular

  • No significant history of cardiac disease
  • No uncontrolled hypertension
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No cardiac ventricular arrhythmias requiring medication

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Able to take oral medication without crushing, dissolving, or chewing tablets
  • No active infection requiring systemic therapy
  • No psychological, familial, sociological, or geographical condition that would preclude study participation or compliance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy, biologic therapy, or gene therapy for the malignancy

Chemotherapy

  • No prior chemotherapy for recurrent disease or newly diagnosed metastatic disease
  • At least 6 months since prior induction or adjuvant chemotherapy

    • No more than 1 prior induction or adjuvant regimen
  • No concurrent chemotherapy for the malignancy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy for the malignancy

Surgery

  • See Disease Characteristics
  • At least 4 weeks since prior surgery and recovered

Other

  • No concurrent therapeutic anticoagulation
  • No other concurrent therapy for the malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096512

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Saint Rose Hospital
Hayward, California, United States, 94545
Highland General Hospital at St. George's University School of Medicine
Oakland, California, United States, 94602
J.C. Robinson, M.D. Regional Cancer Center
San Pablo, California, United States, 94806
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
Summit Medical Center
Oakland, California, United States, 94609
University of California Davis Cancer Center
Davis, California, United States, 95616
Valley Care Medical Center
Pleasanton, California, United States, 94588
United States, Colorado
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Montrose Memorial Hospital Cancer Center
Montrose, Colorado, United States, 81401
St. Anthony North Hospital
Westminster, Colorado, United States, 80030
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80217-3364
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Kansas
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States, 67156
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Salina Regional Health Center
Salina, Kansas, United States, 67401
Southwest Medical Center
Liberal, Kansas, United States, 67901
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Stormont-Vail Cancer Center
Topeka, Kansas, United States, 66604
CCOP - Wichita
Wichita, Kansas, United States, 67214
United States, Louisiana
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States, 71210
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
St. Joseph Mercy Hospital
Pontiac, Michigan, United States, 48341-2985
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Spectrum Health Hospital - Blodgett Campus
Grand Rapids, Michigan, United States, 49506
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
United States, Missouri
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, United States, 63141
David C. Pratt Cancer Center at St. John's Mercy
St. Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau, Missouri, United States, 63701
St. Francis Medical Center
Cape Girardeau, Missouri, United States, 63701
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
United States, Montana
Big Sky Oncology
Great Falls, Montana, United States, 59405
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59101
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59802
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59802
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Sletten Regional Cancer Institute
Great Falls, Montana, United States, 59405
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare
Billings, Montana, United States, 59101
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940
United States, North Carolina
Annie Penn Cancer Center
Reidsville, North Carolina, United States, 27320
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial Hospital
Eden, North Carolina, United States, 27288
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27401
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893
United States, Ohio
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grandview Hospital
Dayton, Ohio, United States, 45405
United States Air Force Medical Center Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
United States, South Carolina
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29304
United States, Tennessee
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
North Puget Oncology at United General Hospital
Sedro-Wooley, Washington, United States, 98284
Group Health Central Hospital
Seattle, Washington, United States, 98104
Harborview Medical Center
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Skagit Valley Hospital Cancer Care Center
Mt. Vernon, Washington, United States, 98273
St. Joseph Hospital Community Cancer Center
Bellingham, Washington, United States, 98225
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98114
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
Wenatchee Valley Clinic
Wenatchee, Washington, United States, 98801
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Investigator: Stephen K. Williamson, MD University of Kansas
Investigator: Chao H. Huang, MD University of Kansas
  More Information

Additional Information:
Publications:
Williamson SK, Moon J, Huang CH, et al.: A phase II trial of sorafenib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC): a Southwest Oncology Group (SWOG) trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-6044, 310s, 2007.
Williamson SK, Moon J, Huang CH, et al.: A phase II trial of BAY 43-9006 in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC): a Southwest Oncology Group (SWOG) trial. [Abstract] J Clin Oncol 24 (Suppl 18): A-5550, 2006.
Williamson S, Moon J, Huang C, et al.: A phase II trial of BAY 43-9006 in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). A Southwest Oncology Group (SWOG) trial. [Abstract] European Journal of Cancer Supplements 3 (2): A-995, 286, 2005.

Study ID Numbers: CDR0000393212, SWOG-S0420
Study First Received: November 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00096512     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
untreated metastatic squamous neck cancer with occult primary

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Head and Neck Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Sorafenib
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009