342
Participants
Start Date
June 28, 2004
Primary Completion Date
March 31, 2011
Study Completion Date
March 31, 2011
Sorafenib
"Step 1 (induction): Sorafenib was giventwice daily for two cycles to all patients. Patients with progression (PD) discontinued treatment. Those who responded after two cycles continued treatment up to 1 year or until PD. With response after 1 year, patients were given the option to continue treatment until PD. Patients who were stable after the end of induction were then randomized onto Step 2 to either continue sorafenib or receive placebo.~Step 2 (randomization): Patients with stable disease after induction will be randomized in a double-blinded manner to placebo or sorafenib. If a patient has progressed, the arm will be unblinded. Patients on placebo with PD can then crossover to receive sorafenib; patients with PD on the sorafenib arm will be removed from the study.~Step 3 (crossover): If patients on placebo progressed within 1 year from randomization, they crossed over to the treatment arm and receive sorafenib for up to 1 year or until PD, unacceptable toxicity, or death."
Placebo
Patients randomized to the placebo arm in step 2 continued receiving placebo until disease progression or one year from randomization. Placebo was given orally twice a day (BID).
Our Lady of Mercy Medical Center Comprehensive Cancer Center, The Bronx
Geisinger Medical Group - Scenery Park, State College
Mount Nittany Medical Center, State College
Central Pennsylvania Hematology and Medical Oncology Associates, PC, Lemoyne
Lewistown Hospital, Lewistown
St. Luke's Cancer Network at St. Luke's Hospital, Bethlehem
Easton Regional Cancer Center at Easton Hospital, Easton
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre
Bryn Mawr Hospital, Bryn Mawr
CCOP - MainLine Health, Wynnewood
Lankenau Cancer Center at Lankenau Hospital, Wynnewood
Joan Karnell Cancer Center at Pennsylvania Hospital, Philadelphia
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston
Baptist Cancer Institute - Jacksonville, Jacksonville
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee, Knoxville
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland
Christ Hospital Cancer Center, Cincinnati
St. Rita's Medical Center, Lima
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte
Saint Anthony Memorial Health Centers, Michigan City
Elkhart General Hospital, Elkhart
CCOP - Northern Indiana CR Consortium, South Bend
Memorial Hospital of South Bend, South Bend
Saint Joseph Regional Medical Center, South Bend
Howard Community Hospital, Kokomo
Clarian Arnett Cancer Care, Lafayette
CCOP - Michigan Cancer Research Consortium, Ann Arbor
Genesys Hurley Cancer Institute, Flint
Hurley Medical Center, Flint
Borgess Medical Center, Kalamazoo
Bronson Methodist Hospital, Kalamazoo
Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph
Foote Hospital, Jackson
Siouxland Hematology-Oncology Associates, LLP, Sioux City
Mercy Medical Center - Sioux City, Sioux City
St. Luke's Regional Medical Center, Sioux City
Cedar Rapids Oncology Associates, Cedar Rapids
Dean Medical Center - Madison, Madison
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay
St. Mary's Hospital Medical Center - Green Bay, Green Bay
Marshfield Clinic - Marshfield Center, Marshfield
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse
United Hospital, Saint Paul
Minnesota Oncology Hematology, PA - Maplewood, Maplewood
Minnesota Oncology Hematology, PA - Woodbury, Woodbury
Fairview Ridges Hospital, Burnsville
Ridgeview Medical Center, Waconia
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis
CCOP - Metro-Minnesota, Saint Louis Park
Park Nicollet Cancer Center, Saint Louis Park
Mercy and Unity Cancer Center at Unity Hospital, Fridley
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids
Fairview Southdale Hospital, Edina
Avera Cancer Institute, Sioux Falls
Medical X-Ray Center, PC, Sioux Falls
Alexian Brothers Radiation Oncology, Elk Grove Village
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey
Joliet Oncology-Hematology Associates, Limited - West, Joliet
Rush-Copley Cancer Care Center, Aurora
Hinsdale Hematology Oncology Associates, Hinsdale
Community Hospital of Ottawa, Ottawa
Oncology Hematology Associates of Central Illinois, PC - Ottawa, Ottawa
Illinois Valley Community Hospital, Peru
Perry Memorial Hospital, Princeton
St. Margaret's Hospital, Spring Valley
Galesburg Clinic, PC, Galesburg
Galesburg Cottage Hospital, Galesburg
Kewanee Hospital, Kewanee
McDonough District Hospital, Macomb
Graham Hospital, Canton
Eureka Community Hospital, Eureka
Cancer Treatment Center at Pekin Hospital, Pekin
Proctor Hospital, Peoria
CCOP - Illinois Oncology Research Association, Peoria
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria
Methodist Medical Center of Illinois, Peoria
OSF St. Francis Medical Center, Peoria
St. Joseph Medical Center, Bloomington
Hopedale Medical Complex, Hopedale
BroMenn Regional Medical Center, Normal
Community Cancer Center, Normal
Carle Cancer Center at Carle Foundation Hospital, Urbana
CCOP - Carle Cancer Center, Urbana
Memorial Hospital, Carthage
Decatur Memorial Hospital Cancer Care Institute, Decatur
Mason District Hospital, Havana
Cancer Center of Kansas, PA - Chanute, Chanute
Cancer Center of Kansas, PA - El Dorado, El Dorado
Cancer Center of Kansas, PA - Salina, Salina
Cancer Center of Kansas, PA - Kingman, Kingman
Cancer Center of Kansas, PA - Newton, Newton
Cancer Center of Kansas, PA - Pratt, Pratt
Cancer Center of Kansas, PA - Wellington, Wellington
Cancer Center of Kansas, PA - Winfield, Winfield
Cancer Center of Kansas, PA - Medical Arts Tower, Wichita
Cancer Center of Kansas, PA - Wichita, Wichita
CCOP - Wichita, Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita
Cancer Center of Kansas, PA - Parsons, Parsons
Cancer Center of Kansas, PA - Dodge City, Dodge City
Southwest Medical Center, Liberal
UT Southwestern University Hospital - Zale Lipshy, Dallas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas
Aurora Presbyterian Hospital, Aurora
Swedish Medical Center, Englewood
Sky Ridge Medical Center, Lone Tree
Porter Adventist Hospital, Denver
Presbyterian - St. Luke's Medical Center, Denver
St. Joseph Hospital, Denver
Rose Medical Center, Denver
North Suburban Medical Center, Thornton
Hope Cancer Care Center at Longmont United Hospital, Longmont
Front Range Cancer Specialists, Fort Collins
Penrose Cancer Center at Penrose Hospital, Colorado Springs
St. Mary - Corwin Regional Medical Center, Pueblo
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction
University Medical Center of Southern Nevada, Las Vegas
CCOP - Nevada Cancer Research Foundation, Las Vegas
Stanford Comprehensive Cancer Center - Stanford, Stanford
Boulder Community Hospital, Boulder
CCOP - Colorado Cancer Research Program, Denver
Swedish-American Regional Cancer Center, Rockford
Morton Hospital & Medical Center, Taunton
Saint Joseph Mercy Cancer Center, Ann Arbor
West Michigan Cancer Center, Kalamazoo
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale
Veterans Affairs Medical Center - East Orange, East Orange
Somerset Medical Center, Somerville
Aultman Cancer Center at Aultman Hospital, Canton
Case Comprehensive Cancer Center, Cleveland
Geisinger Medical Center, Danville
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey
Cancer Center of Paoli Memorial Hospital, Paoli
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls
Vanderbilt-Ingram Cancer Center, Nashville
Fox Valley Hematology and Oncology - East Grant Street, Appleton
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay
St. Vincent Hospital Regional Cancer Center, Green Bay
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc
National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK