Melanoma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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 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)
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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

823

Study ID:

NCT00110019

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 213 Locations for this study

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University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
Mercy Hospital Fort Smith
Ft. 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
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, 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, 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
Center for Cancer Care and Research
Saint Louis Missouri, 63141, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
Saint Louis Missouri, 63141, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
CoxHealth South Hospital
Springfield Missouri, 65807, 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, 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
Montefiore Medical Center-Wakefield Campus
Bronx New York, 10466, 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
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, 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, 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

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

823

Study ID:

NCT00110019

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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