S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
4 other identifiers
interventional
51
1 country
184
Brief Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with advanced soft tissue sarcomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2006
Longer than P75 for phase_2
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
November 1, 2012
CompletedMay 15, 2014
January 1, 2013
2.1 years
September 20, 2005
October 3, 2012
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response (Confirmed, Complete and Partial)
Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.
Assessment performed every eight weeks until progression.
Secondary Outcomes (2)
Four-month Progression-free Survival Rate
0 - 4 months
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Patients were assessed for adverse events two weeks after starting protocol treatment and then after every cycle of treatment (1 cycle = 28 days) for the duration of protocol treatment.
Study Arms (1)
sorafenib
EXPERIMENTALsorafenib
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (184)
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
Peninsula Medical Center
Burlingame, California, 94010, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Marin Cancer Institute at Marin General Hospital
Greenbrae, California, 94904, United States
Sutter Health - Western Division Cancer Research Group
Greenbrae, California, 94904, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089-9181, United States
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, 92120, United States
California Pacific Medical Center - California Campus
San Francisco, California, 94118, United States
Sutter Solano Medical Center
Vallejo, California, 94589, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80524, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435, United States
Trinity Medical Center - East
Moline, Illinois, 61265, United States
Unknown Facility
Moline, Illinois, 61265, United States
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, 47374, United States
Unknown Facility
Bettendorf, Iowa, 52722, United States
Mercy Capitol Hospital
Des Moines, Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, 50266, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, 49017, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Metro Health Hospital
Grand Rapids, Michigan, 49506, United States
Holland Community Hospital
Holland, Michigan, 49423, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, 49801, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazooaa, Michigan, 49001, United States
Hackley Hospital
Muskegon, Michigan, 49442, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, 55422-2900, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Health Services
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, 55125, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
St. Vincent Healthcare
Billings, Montana, 59101, United States
Billings Clinic Cancer Center
Billings, Montana, 59107-5100, United States
Deaconess Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Community Hospital
Butte, Montana, 59701, United States
Big Sky Oncology
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131-5636, United States
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, 12801, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, 10940-4199, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, 13057, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Wilson Medical Center
Wilson, North Carolina, 27893-3428, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Community Oncology Group at Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Middletown Regional Hospital
Middletown, Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson AFB, Ohio, 45433-5529, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, 44501, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland, Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, 97227, United States
Oregon Health & Science University Cancer Institute
Portland, Oregon, 97239-3098, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
McLeod Regional Medical Center
Florence, South Carolina, 29501, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37662, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Southwest Virginia Regional Cancer Center
Norton, Virginia, 24273, United States
St. Joseph Cancer Center
Bellingham, Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton, Washington, 98310, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98104, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical, PLLC
Seattle, Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307, United States
Polyclinic First Hill
Seattle, Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195-6043, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, 99204, United States
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, 99207, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98668, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, 54449, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Ryan CW, von Mehren M, Rankin CJ, et al.: Phase II intergroup study of sorafenib (S) in advanced soft tissue arcomas (STS): SWOG 0505. [Abstract] J Clin Oncol 26 (Suppl 15): A-10532, 2008.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG Statistical Center
Study Officials
- STUDY CHAIR
Margaret von Mehren, MD
Fox Chase Cancer Center
- STUDY CHAIR
George D. Demetri, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
March 1, 2006
Primary Completion
April 1, 2008
Study Completion
September 1, 2012
Last Updated
May 15, 2014
Results First Posted
November 1, 2012
Record last verified: 2013-01