S0505 Sorafenib in Treating Patients With Advanced Soft Tissue Sarcomas
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult angiosarcoma, adult leiomyosarcoma, adult liposarcoma, adult malignant hemangiopericytoma, recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma of 1 of the following histologies: Angiosarcoma, cutaneous or visceral Malignant hemangiosarcoma Malignant hemangiopericytoma Grade 3-4 leiomyosarcoma Grade 3-4 liposarcoma Must have evidence of unresectable residual disease, metastatic disease, or recurrent disease by radiography Measurable disease by x-ray, scans, or physical examination Archived paraffin-embedded tumor sections available No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastases) Bilirubin normal (≤ 2.5 times ULN if due to liver metastases) PT, PTT, and INR normal Renal Creatinine normal OR Creatinine clearance ≥ 60 mL/min Cardiovascular No history of thromboembolic disease No uncontrolled hypertension Other Not pregnant or nursing Fertile patients must use effective contraception Able to swallow oral medication 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 Not specified Chemotherapy At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and recovered Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease Endocrine therapy Not specified Radiotherapy At least 28 days since prior radiotherapy and recovered Must have evidence of disease progression within, or measurable disease outside of, the radiation field after completion of radiotherapy Surgery At least 28 days since prior major surgery and recovered Other No prior sorafenib No prior inhibitor of VEGFR or MAPK pathway No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No concurrent therapeutic anticoagulation No concurrent administration of any of the following medications: Rifampin Hypericum perforatum (St. John's wort) Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following: Phenytoin Carbamazepine Phenobarbital
Sites / Locations
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Comprehensive Cancer Center
- Peninsula Medical Center
- City of Hope Comprehensive Cancer Center
- Marin Cancer Institute at Marin General Hospital
- Sutter Health - Western Division Cancer Research Group
- USC/Norris Comprehensive Cancer Center and Hospital
- Kaiser Permanente Medical Office -Vandever Medical Office
- California Pacific Medical Center - California Campus
- Sutter Solano Medical Center
- Front Range Cancer Specialists
- Poudre Valley Hospital
- M.D. Anderson Cancer Center Orlando
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Rush-Copley Cancer Care Center
- Decatur Memorial Hospital Cancer Care Institute
- Joliet Oncology-Hematology Associates, Limited - West
- Trinity Medical Center - East
- Regional Cancer Center at Memorial Medical Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- Reid Hospital & Health Care Services, Incorporated
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Tammy Walker Cancer Center at Salina Regional Health Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Battle Creek Health System Cancer Care Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Green Bay Oncology, Limited - Escanaba
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Spectrum Health Hospital - Butterworth Campus
- Metro Health Hospital
- Holland Community Hospital
- Green Bay Oncology, Limited - Iron Mountain
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Hackley Hospital
- Munson Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA at Maplewood Cancer Center
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- CCOP - Kansas City
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- Siteman Cancer Center at Barnes-Jewish Hospital
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Community Hospital
- Big Sky Oncology
- Great Falls Clinic
- Sletten Regional Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- University of New Mexico Cancer Research and Treatment Center
- Adirondack Cancer Care - Glens Falls
- Charles R. Wood Cancer Center at Glens Falls Hospital
- Tucker Center for Cancer Care at Orange Regional Medical Center
- CCOP - Hematology-Oncology Associates of Central New York
- Presbyterian Cancer Center at Presbyterian Hospital
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Rutherford Hospital
- Wilson Medical Center
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Community Oncology Group at Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- St. Rita's Medical Center
- Middletown Regional Hospital
- UVMC Cancer Care Center at Upper Valley Medical Center
- Cleveland Clinic - Wooster
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Tod Children's Hospital - Forum Health
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center & Children's Hospital
- Oregon Health & Science University Cancer Institute
- Legacy Meridian Park Hospital
- Fox Chase Cancer Center - Philadelphia
- AnMed Cancer Center
- McLeod Regional Medical Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Medical City Dallas Hospital
- Brooke Army Medical Center
- Wilford Hall Medical Center
- Huntsman Cancer Institute at University of Utah
- Danville Regional Medical Center
- Southwest Virginia Regional Cancer Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- Providence Cancer Center at Sacred Heart Medical Center
- Providence Cancer Center at Holy Family Hospital
- Southwest Washington Medical Center Cancer Center
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Marshfield Clinic - Marshfield Center
- Green Bay Oncology, Limited - Oconto Falls
- Marshfield Clinic - Indianhead Center
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
sorafenib
sorafenib