Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas
OBJECTIVES:
- Determine the objective response rate (confirmed, complete, and partial) in patients
with advanced soft tissue sarcomas treated with sorafenib.
- Determine the 4-month progression-free survival rate in patients treated with this
drug.
- Determine the frequency and severity of adverse events in patients treated with this
drug.
OTHER OBJECTIVES (if funding permits):
- Correlate, preliminarily, a decrease in standard uptake variable (SUV) of target
lesions by positron-emission tomography scan at 4 weeks with response in patients
treated with this drug.
- Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the
raf/mek/erk pathway with response in patients treated with this drug.
- Correlate, preliminarily, the most common B-raf kinase mutation with response in
patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to histology
(leiomyosarcoma vs liposarcoma vs angiosarcoma, hemangiosarcoma, or hemangiopericytoma).
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 8 weeks until disease
progression and then every 6 months for 2 years and annually for up to 3 years.
PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per stratum) will be accrued for this
study within 15-38 months.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
No
Margaret von Mehren, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
NCI-2012-03063
NCT00217620
March 2006
September 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
St. Rita's Medical Center | Lima, Ohio 45801 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
CCOP - Dayton | Kettering, Ohio 45429 |
Hinsdale, Illinois 60521 | |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Great Falls Clinic | Great Falls, Montana 59405 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Tod Children's Hospital - Forum Health | Youngstown, Ohio 44501 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Southwest Medical Center | Liberal, Kansas 67901 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Holland Community Hospital | Holland, Michigan 49423 |
Hackley Hospital | Muskegon, Michigan 49443 |
Munson Medical Center | Traverse City, Michigan 49684 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
St. James Community Hospital | Butte, Montana 59701 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Alta Bates Comprehensive Cancer Center | Berkeley, California 94704 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Marin Cancer Institute at Marin General Hospital | Greenbrae, California 94904 |
Kaiser Permanente Medical Office -Vandever Medical Office | San Diego, California 92120 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Trinity Medical Center - East | Moline, Illinois 61265 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Reid Hospital & Health Care Services, Incorporated | Richmond, Indiana 47374 |
Bettendorf, Iowa 52722 | |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Adirondack Cancer Care - Glens Falls | Glens Falls, New York 12801 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Southwest Virginia Regional Cancer Center | Norton, Virginia 24273 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Providence Cancer Center at Holy Family Hospital | Spokane, Washington 99207 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Oregon Health & Science University Cancer Institute | Portland, Oregon 97239-3098 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Minnesota Oncology Hematology, PA at Maplewood Cancer Center | Maplewood, Minnesota 55109 |
M.D. Anderson Cancer Center Orlando | Orlando, Florida 32806 |