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Spots Global Cancer Trial Database for Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Keith Flaherty

Affiliation: ECOG-ACRIN Cancer Research Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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