AzTrials
AzTrials

Mucosal MelanomaPhase 3NCT00110019

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 Phase 3 study testing Carboplatin, Laboratory Biomarker Analysis and Paclitaxel in people with Mucosal Melanoma and Recurrent Melanoma, run by National Cancer Institute (NCI) at 219 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Laboratory Biomarker Analysis and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
823 participants
Where
219 sitesin 2 countries
Study dates
Jun 2005to Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 28Show fewer
  • 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)
  • 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

Who cannot join

None listed.

Trial locations and contacts

219 sites in 2 countries.

219 sites in 2 countries

United States218 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Fox Valley Hematology and Oncology

    Appleton, Wisconsin, 54911

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Atlanta Regional CCOP

    Atlanta, Georgia, 30342

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institute-Billings

    Billings, Montana, 59102

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • IU Health Bloomington

    Bloomington, Indiana, 47403

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • West Virginia University Charleston

    Charleston, West Virginia, 25304

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Martha Jefferson Hospital

    Charlottesville, Virginia, 22901

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Columbus CCOP

    Columbus, Ohio, 43215

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Delaware County Memorial Hospital

    Drexel Hill, Pennsylvania, 19026

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Oncology Hematology Associates of Northern Pennsylvania

    DuBois, Pennsylvania, 15801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Veterans Adminstration New Jersey Health Care System

    East Orange, New Jersey, 07018-1095

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Aurora Cancer Care-Southern Lakes

    Elkhorn, Wisconsin, 53121

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Hurley Medical Center

    Flint, Michigan, 48502

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Southwest Florida Regional Medical Center

    Fort Meyers, Florida, 33901

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • University of Florida

    Gainesville, Florida, 32610

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Marin Cancer Care Inc

    Greenbrae, California, 94904

  • East Carolina University

    Greenville, North Carolina, 27858

  • Hackensack University Medical CCOP

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates-Hampton

    Hampton, Virginia, 23666

  • PinnacleHealth Cancer Center-Community Campus

    Harrisburg, Pennsylvania, 17109

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hinsdale Hematology Oncology Associates Incorporated

    Hinsdale, Illinois, 60521

  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital

    Hollywood, Florida, 33021

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Saint Mary's Medical Center

    Huntington, West Virginia, 25702

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Freeman Health System

    Joplin, Missouri, 64804

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • East Tennessee Baptist Hospital-Mercy Health Partners

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Medical Center of Central Georgia

    Macon, Georgia, 31208

  • Dean Hematology and Oncology Clinic

    Madison, Wisconsin, 53717

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Trinity Medical Center

    Moline, Illinois, 61265

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University

    New Haven, Connecticut, 06520

  • Laura and Issac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Western Oncology Research Consortium

    Portland, Oregon, 97213

  • Kaiser Permanente

    Portland, Oregon, 97227

  • Pottstown Memorial Medical Center

    Pottstown, Pennsylvania, 19464

  • MidHudson Regional Hospital of Westchester Medical Center

    Poughkeepsie, New York, 12601

  • Kansas City CCOP

    Prairie Village, Kansas, 66208

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Interlakes Foundation Inc-Rochester

    Rochester, New York, 14623

  • University of Rochester

    Rochester, New York, 14642

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Oncology Care Associates PLLC

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Veterans Administration-San Diego Medical Center

    San Diego, California, 92161

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • California Pacific Medical Center-Pacific Campus

    San Francisco, California, 94118

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Santa Rosa Memorial Hospital

    Sana Rosa, California, 95405

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Hematology and Oncology Associates of North East Pennsylvania

    Scranton, Pennsylvania, 18508

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Group Health Cooperative-Seattle

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center-Wakefield Campus

    The Bronx, New York, 10466

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Kent County Hospital

    Warwick, Rhode Island, 02886

  • Cedar Valley Medical Specialists

    Waterloo, Iowa, 50701

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Chester County Hospital

    West Chester, Pennsylvania, 19380

  • Jennersville Regional Hospital

    West Grove, Pennsylvania, 19390

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Main Office

    Wichita, Kansas, 67214

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Cleveland Clinic Wooster Specialty Center

    Wooster, Ohio, 44691

  • Commonwealth Hematology Oncology PC-Worcester

    Worcester, Massachusetts, 01605

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405

Other trials in United States

Australia1 site

  • Sydney West Area Health Service-Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Carboplatin, Laboratory Biomarker Analysis, Paclitaxel, Pharmacological Study, Placebo
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Pharmacological StudyOther

    Correlative studies

  • PlaceboOther

    Also called placebo therapy, PLCB, sham therapy

    Given PO

  • Sorafenib TosylateDrug

    Also called BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib

    Given PO

Study groups in NCT00110019
Study groupRoleWhat they receive
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.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Pharmacological Study; Drug: Sorafenib Tosylate
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.
Receives: Drug: Carboplatin; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Other: Pharmacological Study; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Progression-free Survival

    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.

    Measured: 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.

  2. Objective Response (Complete and Partial Response) Rate

    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.

    Measured: Tumor response was assessed after every 2 cycles during cycle 1 through 10. After cycle 10, tumor response was assessed after every 3 cycles.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJan 2011
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110019
Sponsor's protocol ID
NCI-2012-02978
Other IDs
NCI-2012-02978, E2603, E2603, U10CA180820, U10CA021115
Status last verified
Jul 2015
First submitted
3 May 2005
Last updated
19 Oct 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23248256

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Laboratory Biomarker Analysis and Paclitaxel in people with Mucosal Melanoma and Recurrent Melanoma, run by National Cancer Institute (NCI) at 219 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 219 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00110019, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.

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