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Brief Title: Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Official Title: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial of Carboplatin, Paclitaxel and Sorafenib Versus Carboplatin, Paclitaxel and Placebo in Patients With Unresectable Locally Advanced or Stage IV Melanoma
Study ID: NCT00110019
Brief Summary: This randomized phase III trial studies carboplatin, paclitaxel, and sorafenib tosylate to see how well they work compared to carboplatin and paclitaxel in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate 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. It is not yet known whether giving carboplatin and paclitaxel together with sorafenib tosylate is more effective than carboplatin and paclitaxel in treating melanoma.
Detailed Description: PRIMARY OBJECTIVES: I. To compare the overall survival of patients with unresectable stage III or stage IV melanoma treated with carboplatin, paclitaxel and placebo versus carboplatin, paclitaxel and sorafenib (sorafenib tosylate). II. To compare progression-free survival, response rate, and safety of patients with unresectable stage III or stage IV melanoma treated with carboplatin, paclitaxel and placebo versus carboplatin, paclitaxel and sorafenib. III. To analyze the pharmacokinetic and pharmacogenetic properties of sorafenib including angiogenesis, monooxygenases polymorphisms and multidrug resistance (MDR). IV. To assess the association of expression markers in the patient tumor with clinical outcome. OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive sorafenib tosylate orally (PO) twice daily (BID) (approximately every 12 hours) on days 2-19. Arm II: Patients receive paclitaxel and carboplatin as in Arm I. Patients also receive placebo PO BID (approximately every 12 hours) on days 2-19. In both arms, treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or who achieve a partial response or complete response may continue to receive sorafenib tosylate or placebo alone BID (approximately every 12 hours) on days 1-21. Courses with sorafenib tosylate or placebo repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Mercy Hospital Fort Smith, Ft. Smith, Arkansas, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Marin Cancer Care Inc, Greenbrae, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Saint Joseph Hospital - Orange, Orange, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
Kaiser Permanente-Redwood City, Redwood City, California, United States
Kaiser Permanente-Richmond, Richmond, California, United States
Kaiser Permanente-Roseville, Roseville, California, United States
Kaiser Permanente - Sacramento, Sacramento, California, United States
Kaiser Permanente-San Diego Mission, San Diego, California, United States
Veterans Administration-San Diego Medical Center, San Diego, California, United States
Kaiser Permanente-San Francisco, San Francisco, California, United States
California Pacific Medical Center-Pacific Campus, San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, United States
Santa Rosa Memorial Hospital, Sana Rosa, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Kaiser Permanente-Santa Rosa, Santa Rosa, California, United States
Kaiser Permanente-Vallejo, Vallejo, California, United States
The Medical Center of Aurora, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Exempla Saint Joseph Hospital, Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Broward Health Medical Center, Fort Lauderdale, Florida, United States
Southwest Florida Regional Medical Center, Fort Meyers, Florida, United States
University of Florida, Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
Jupiter Medical Center, Jupiter, Florida, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Florida Hospital Orlando, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Piedmont Hospital, Atlanta, Georgia, United States
Atlanta Regional CCOP, Atlanta, Georgia, United States
Dekalb Medical Center, Decatur, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
Southern Regional Medical Center, Riverdale, Georgia, United States
South Georgia Medical Center, Valdosta, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Swedish Covenant Hospital, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Advocate Sherman Hospital, Elgin, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated, Hinsdale, Illinois, United States
Trinity Medical Center, Moline, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Carle Clinic-Urbana Main, Urbana, Illinois, United States
IU Health Bloomington, Bloomington, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Franciscan Saint Anthony Health-Michigan City, Michigan City, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka, Mishawaka, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Physicians' Clinic of Iowa PC, Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Association, Cedar Rapids, Iowa, United States
Heartland Oncology and Hematology LLP, Council Bluffs, Iowa, United States
Genesis Medical Center - East Campus, Davenport, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Cedar Valley Medical Specialists, Waterloo, Iowa, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
Kansas City CCOP, Prairie Village, Kansas, United States
Salina Regional Health Center, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Main Office, Wichita, Kansas, United States
Central Maine Medical Center, Lewiston, Maine, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Frederick Memorial Hospital, Frederick, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Commonwealth Hematology Oncology PC-Worcester, Worcester, Massachusetts, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Oncology Care Associates PLLC, Saint Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
Unity Hospital, Fridley, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota, United States
Singing River Hospital, Pascagoula, Mississippi, United States
Freeman Health System, Joplin, Missouri, United States
Center for Cancer Care and Research, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Montana Cancer Consortium NCORP, Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings, Billings, Montana, United States
Nevada Cancer Research Foundation CCOP, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Veterans Adminstration New Jersey Health Care System, East Orange, New Jersey, United States
Hackensack University Medical CCOP, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Montefiore Medical Center-Wakefield Campus, Bronx, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse, East Syracuse, New York, United States
Glens Falls Hospital, Glens Falls, New York, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
MidHudson Regional Hospital of Westchester Medical Center, Poughkeepsie, New York, United States
Interlakes Foundation Inc-Rochester, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
State University of New York Upstate Medical University, Syracuse, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
East Carolina University, Greenville, North Carolina, United States
Mid Dakota Clinic, Bismarck, North Dakota, United States
Sanford Medical Center-Fargo, Fargo, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
Mercy Medical Center, Canton, Ohio, United States
Aultman Health Foundation, Canton, Ohio, United States
Adena Regional Medical Center, Chillicothe, Ohio, United States
The Christ Hospital, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Columbus CCOP, Columbus, Ohio, United States
Grant Medical Center, Columbus, Ohio, United States
Mount Carmel Health Center West, Columbus, Ohio, United States
Doctors Hospital, Columbus, Ohio, United States
Grady Memorial Hospital, Delaware, Ohio, United States
Cleveland Clinic Cancer Center Independence, Independence, Ohio, United States
Saint Rita's Medical Center, Lima, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Cleveland Clinic Wooster Specialty Center, Wooster, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Oklahoma City, Oklahoma, United States
Western Oncology Research Consortium, Portland, Oregon, United States
Kaiser Permanente, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Oncology Hematology Associates of Northern Pennsylvania, Dubois, Pennsylvania, United States
PinnacleHealth Cancer Center-Community Campus, Harrisburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
Saint Mary Medical and Regional Cancer Center, Langhorne, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Pottstown Memorial Medical Center, Pottstown, Pennsylvania, United States
Hematology and Oncology Associates of North East Pennsylvania, Scranton, Pennsylvania, United States
Scranton Hematology Oncology, Scranton, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Chester County Hospital, West Chester, Pennsylvania, United States
Jennersville Regional Hospital, West Grove, Pennsylvania, United States
Lankenau Medical Center, Wynnewood, Pennsylvania, United States
WellSpan Health-York Hospital, York, Pennsylvania, United States
Kent County Hospital, Warwick, Rhode Island, United States
Medical University of South Carolina, Charleston, South Carolina, United States
McLeod Regional Medical Center, Florence, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Sanford Cancer Center-Oncology Clinic, Sioux Falls, South Dakota, United States
Erlanger Medical Center, Chattanooga, Tennessee, United States
East Tennessee Baptist Hospital-Mercy Health Partners, Knoxville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
University of Vermont College of Medicine, Burlington, Vermont, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Danville Regional Medical Center, Danville, Virginia, United States
Virginia Oncology Associates-Hampton, Hampton, Virginia, United States
Group Health Cooperative-Seattle, Seattle, Washington, United States
Swedish Medical Center-First Hill, Seattle, Washington, United States
West Virginia University Charleston, Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center, Huntington, West Virginia, United States
Saint Mary's Medical Center, Huntington, West Virginia, United States
West Virginia University Healthcare, Morgantown, West Virginia, United States
Fox Valley Hematology and Oncology, Appleton, Wisconsin, United States
Aurora Cancer Care-Southern Lakes, Elkhorn, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Dean Hematology and Oncology Clinic, Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Sydney West Area Health Service-Westmead Hospital, Westmead, New South Wales, Australia
Name: Keith Flaherty
Affiliation: ECOG-ACRIN Cancer Research Group
Role: PRINCIPAL_INVESTIGATOR