Carboplatin and Paclitaxel With or Without Sorafenib Tosylate in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00110019
First received: May 3, 2005
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Mucosal Melanoma
Recurrent Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Drug: paclitaxel
Drug: carboplatin
Drug: sorafenib tosylate
Other: placebo
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Progression-free survival was defined as time from study entry to disease progression or death from any cause, whichever occurred first. Patients without disease progression were censored at last date of assessment. Disease progression was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.

  • Objective Response (Complete and Partial Response) Rate [ Time Frame: Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles. ] [ Designated as safety issue: No ]
    Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Objective response =complete response (CR) + partial response (PR). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of longest diameters.


Enrollment: 823
Study Start Date: June 2005
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (paclitaxel, carboplatin, sorafenib tosylate)
Patients 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.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Drug: sorafenib tosylate
Given PO
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: Arm II (carboplatin, paclitaxel, placebo)
Patients receive paclitaxel and carboplatin as in Arm I. Patients also receive placebo PO BID (approximately every 12 hours) on days 2-19.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Other: placebo
Given PO
Other Name: PLCB
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Ras, 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)
  • International normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) within normal limits (patients who are on therapeutic anticoagulation with warfarin should have documentation of a normal prothrombin time [PT]/PTT prior to initiating that therapy)
  • Patients must not have ocular melanoma
  • Patients must have discontinued immunotherapy or radiation therapy at least 4 weeks prior to initiation of treatment and recovered from adverse events due to those agents
  • Patients must not receive any other investigational agents during the period on study or the four weeks prior to initiation of treatment
  • Patients must not have a history or clinical evidence of brain metastasis; patients must be evaluated with a head magnetic resonance imaging (MRI) within 4 weeks prior to enrollment
  • Patients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for >= 5 years prior to the time of randomization
  • Patients must not have any evidence of bleeding diathesis
  • Patients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics, clinically significant cardiovascular disease (e.g. uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's Wort
  • Women must not be pregnant or breast-feeding
  • All females of childbearing potential must have a blood test or urine study within 4 weeks prior to registration to rule out pregnancy
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately as well
  • Human immunodeficiency virus (HIV)-positive patients are excluded from the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110019

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Saint Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
City of Hope
Duarte, California, United States, 91010
Marin Cancer Care Inc
Greenbrae, California, United States, 94904
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
Bay Area Tumor Institute CCOP
Oakland, California, United States, 94609
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
Kaiser Permanente-Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente-Richmond
Richmond, California, United States, 94801
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Kaiser Permanente - Sacramento
Sacramento, California, United States, 95825
Veterans Administration-San Diego Medical Center
San Diego, California, United States, 92161
Kaiser Permanente
San Diego, California, United States, 92120
California Pacific Medical Center
San Francisco, California, United States, 94118
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Santa Rosa Memorial Hospital
Sana Rosa, California, United States, 95405
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80113
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
North Suburban Medical Center
Thornton, Colorado, United States, 80229
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale University
New Haven, Connecticut, United States, 06520
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Southwest Florida Regional Medical Center
Fort Meyers, Florida, United States, 33901
University of Florida
Gainesville, Florida, United States, 32610
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Edna Williams Cancer Center at the Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
Florida Hospital
Orlando, Florida, United States, 32803
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
South Georgia Medical Center
Valdosta, Georgia, United States, 31603
United States, Hawaii
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Swedish Covenant Hospital
Chicago, Illinois, United States, 60625
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Advocate Sherman Hospital
Elgin, Illinois, United States, 60123
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Trinity Medical Center
Moline, Illinois, United States, 61265
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
IU Health Bloomington
Bloomington, Indiana, United States, 47403
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States, 52402
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Cedar Valley Medical Specialists
Waterloo, Iowa, United States, 50701
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Salina Regional Health Center
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
United States, Maine
Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Commonwealth Hematology Oncology PC-Worcester
Worcester, Massachusetts, United States, 01605
United States, Michigan
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Oncology Care Associates PLLC
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Unity Hospital
Fridley, Minnesota, United States, 55432
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Freeman Health System
Joplin, Missouri, United States, 64804
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Saint Louis-Cape Girardeau CCOP
Saint Louis, Missouri, United States, 63141
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Montana
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Hackensack University Medical CCOP
Hackensack, New Jersey, United States, 07601
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Montefiore Medical Center-Wakefield Campus
Bronx, New York, United States, 10466
Hematology Oncology Associates of Central New York PC-East Syracuse
East Syracuse, New York, United States, 13057
Glens Falls Hospital
Glens Falls, New York, United States, 12801
New York University Langone Medical Center
New York, New York, United States, 10016
Saint Francis
Poughkeepsie, New York, United States, 12601
Interlakes Foundation Inc-Rochester
Rochester, New York, United States, 14623
University of Rochester
Rochester, New York, United States, 14642
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
East Carolina University
Greenville, North Carolina, United States, 27858
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Aultman Health Foundation
Canton, Ohio, United States, 44710
Mercy Medical Center
Canton, Ohio, United States, 44708
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Doctors Hospital
Columbus, Ohio, United States, 43228
Columbus CCOP
Columbus, Ohio, United States, 43215
Grant Medical Center
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73120
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Kaiser Permanente
Portland, Oregon, United States, 97227
Western Oncology Research Consortium
Portland, Oregon, United States, 97213
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Oncology Hematology Associates of Northern Pennsylvania
Dubois, Pennsylvania, United States, 15801
PinnacleHealth Cancer Center-Community Campus
Harrisburg, Pennsylvania, United States, 17109
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15232
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, United States, 18508
Scranton Hematology Oncology
Scranton, Pennsylvania, United States, 18510
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Jennersville Regional Hospital
West Grove, Pennsylvania, United States, 19390
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, Rhode Island
Kent County Hospital
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
East Tennessee Baptist Hospital-Mercy Health Partners
Knoxville, Tennessee, United States, 37920
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Virginia Oncology Associates-Hampton
Hampton, Virginia, United States, 23666
United States, Washington
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States, 25701
Saint Mary's Medical Center
Huntington, West Virginia, United States, 25702
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States, 54911-3496
Aurora Cancer Care-Southern Lakes
Elkhorn, Wisconsin, United States, 53121
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Sydney West Area Health Service-Westmead Hospital
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
Investigators
Principal Investigator: Keith Flaherty ECOG-ACRIN Cancer Research Group
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00110019     History of Changes
Other Study ID Numbers: NCI-2012-02978, NCI-2012-02978, E2603, E2603, E2603, U10CA021115, U10CA180820
Study First Received: May 3, 2005
Results First Received: August 28, 2012
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Sorafenib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014