Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
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
4 other identifiers
interventional
823
2 countries
219
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
Longer than P75 for phase_3
219 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2005
CompletedFirst Posted
Study publicly available on registry
May 4, 2005
CompletedStudy Start
First participant enrolled
June 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
September 27, 2012
CompletedOctober 19, 2015
July 1, 2015
5.6 years
May 3, 2005
August 28, 2012
September 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined as time from study entry to death from any cause. The comparison of overall survival was conducted in intention-to-treat population.
Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.
Secondary Outcomes (2)
Progression-free Survival
Tumor response was assessed after every 2 cycles during cycle 1 through 10, and every 3 cycles after cycle 10. Survival was assessed every 3 months if patient is < 2 years from study entry, and every 6 months if 2-5 years from study entry.
Objective Response (Complete and Partial Response) Rate
Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.
Study Arms (2)
Arm I (paclitaxel, carboplatin, sorafenib tosylate)
EXPERIMENTALPatients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive sorafenib tosylate PO BID (approximately every 12 hours) on days 2-19.
Arm II (carboplatin, paclitaxel, placebo)
ACTIVE COMPARATORPatients receive paclitaxel and carboplatin as in Arm I. Patients also receive placebo PO BID (approximately every 12 hours) on days 2-19.
Interventions
Given IV
Correlative studies
Given IV
Correlative studies
Given PO
Given PO
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmed melanoma that is metastatic or unresectable; patients must have a history of cutaneous, mucosal or unknown primary site
- Patients who have received prior systemic cytotoxic chemotherapy for treatment of melanoma are ineligible; the following groups are eligible with regard to prior systemic therapy either in the adjuvant or metastatic disease setting:
- No prior therapy
- Immunotherapy consisting of interferon, interleukin-2, granulocyte macrophage colony-stimulating factor (GM-CSF) or vaccine
- One prior investigational therapy (cannot be chemotherapy or an inhibitor of rat sarcoma \[Ras\], serine/threonine kinase \[Raf\], or mitogen-activated protein kinase kinase \[MEK\])
- NOTE: Chemotherapy given via isolated limb perfusion is allowed
- Prior radiation therapy is allowed; however, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions
- All sites of disease must be evaluated within 4 weeks of registration; patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White blood count \>= 3,000/mm\^3
- Absolute granulocyte count \>= 1,500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Serum creatinine =\< 2.0 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) \>= 40 ml/min (neither drug is cleared by the kidney)
- Total bilirubin =\< 1.5 x ULN (\< 3.0 x ULN in the presence of Gilbert's disease)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN (=\< 5.0 ULN in the presence of liver metastases)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (219)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
Marin Cancer Care Inc
Greenbrae, California, 94904, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Saint Joseph Hospital - Orange
Orange, California, 92868, United States
Stanford Cancer Institute
Palo Alto, California, 94304, United States
Kaiser Permanente-Redwood City
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
Kaiser Permanente - Sacramento
Sacramento, California, 95825, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Veterans Administration-San Diego Medical Center
San Diego, California, 92161, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, 94118, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Santa Rosa Memorial Hospital
Sana Rosa, California, 95405, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University
New Haven, Connecticut, 06520, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Southwest Florida Regional Medical Center
Fort Meyers, Florida, 33901, United States
University of Florida
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Baptist Cancer Institute
Jacksonville, Florida, 32207, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Atlanta Regional CCOP
Atlanta, Georgia, 30342, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Medical Center of Central Georgia
Macon, Georgia, 31208, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
South Georgia Medical Center
Valdosta, Georgia, 31603, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Swedish Covenant Hospital
Chicago, Illinois, 60625, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, 60521, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Carle Clinic-Urbana Main
Urbana, Illinois, 61801, United States
IU Health Bloomington
Bloomington, Indiana, 47403, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403, United States
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Cedar Valley Medical Specialists
Waterloo, Iowa, 50701, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Kansas City CCOP
Prairie Village, Kansas, 66208, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
Central Maine Medical Center
Lewiston, Maine, 04240, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Commonwealth Hematology Oncology PC-Worcester
Worcester, Massachusetts, 01605, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, 59102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Hackensack University Medical CCOP
Hackensack, New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Laura and Issac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
MidHudson Regional Hospital of Westchester Medical Center
Poughkeepsie, New York, 12601, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, 10466, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, 58122, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Columbus CCOP
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73120, United States
Western Oncology Research Consortium
Portland, Oregon, 97213, United States
Kaiser Permanente
Portland, Oregon, 97227, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026, United States
Oncology Hematology Associates of Northern Pennsylvania
DuBois, Pennsylvania, 15801, United States
PinnacleHealth Cancer Center-Community Campus
Harrisburg, Pennsylvania, 17109, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, 19464, United States
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, 18508, United States
Scranton Hematology Oncology
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Chester County Hospital
West Chester, Pennsylvania, 19380, United States
Jennersville Regional Hospital
West Grove, Pennsylvania, 19390, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17405, United States
Kent County Hospital
Warwick, Rhode Island, 02886, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
East Tennessee Baptist Hospital-Mercy Health Partners
Knoxville, Tennessee, 37920, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22901, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Virginia Oncology Associates-Hampton
Hampton, Virginia, 23666, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
Saint Mary's Medical Center
Huntington, West Virginia, 25702, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Fox Valley Hematology and Oncology
Appleton, Wisconsin, 54911, United States
Aurora Cancer Care-Southern Lakes
Elkhorn, Wisconsin, 53121, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Dean Hematology and Oncology Clinic
Madison, Wisconsin, 53717, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Sydney West Area Health Service-Westmead Hospital
Westmead, New South Wales, 2145, Australia
Related Publications (1)
Flaherty KT, Lee SJ, Zhao F, Schuchter LM, Flaherty L, Kefford R, Atkins MB, Leming P, Kirkwood JM. Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma. J Clin Oncol. 2013 Jan 20;31(3):373-9. doi: 10.1200/JCO.2012.42.1529. Epub 2012 Dec 17.
PMID: 23248256DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Keith Flaherty
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2005
First Posted
May 4, 2005
Study Start
June 1, 2005
Primary Completion
January 1, 2011
Study Completion
August 1, 2012
Last Updated
October 19, 2015
Results First Posted
September 27, 2012
Record last verified: 2015-07