|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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 |
| Study Start Date: | October 2004 |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck meeting 1 of the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
At least 6 months since prior induction or adjuvant chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study 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 | |
| Investigator: | Stephen K. Williamson, MD | University of Kansas |
| Investigator: | Chao H. Huang, MD | University of Kansas |
More Information
| 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 |
|
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 |
|
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 |