Trial Condition(s):

Melanoma

A Treatment Combination for Patients with Unresectable Stage III or Stage IV Melanoma

Bayer Identifier:

11718

ClinicalTrials.gov Identifier:

NCT00111007

EudraCT Number:

2005-000941-12

Study Completed

Trial Purpose

The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).

Inclusion Criteria
- Subjects who have a life expectancy of at least 12 weeks
 - Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
 - Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
 - Subjects who have an ECOG PS of 0 or 1
 - Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion Criteria
- Primary ocular or mucosal melanoma
 - Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]& T1 [Tumor invades subepithelial connective tissue]) or any cancer curatively treated < 5 years prior to study entry
 - History of cardiac disease
 - Known history of human immunodeficiency virus (HIV) infection

Trial Summary

Enrollment Goal
270
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

Krankenhaus Nordwest

Frankfurt, Germany, 60488

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68135

Status
Completed
 
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Guy's Hospital

London, United Kingdom, SE1 9RT

Status
Terminated
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Clatterbridge Centre for Oncology

Bebington, United Kingdom, CH63 4JY

Status
Terminated
 
Locations

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Nottingham City Hospital

Nottingham, United Kingdom, NG5 1PB

Status
Completed
 
Locations

Singleton Hospital

Swansea, United Kingdom, SA2 8QA

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

University of Pittsburgh Medical Center Health System

Pittsburgh, United States, 15232

Status
Completed
 
Locations

University of Arizona Cancer Center

Tucson, United States, 85724

Status
Completed
 
Locations

Nebraska Methodist Hospital

Omaha, United States, 68114

Status
Completed
 
Locations

Office of Dr. Sewa Legha, MD

Houston, United States, 77030

Status
Completed
 
Locations

University of Alabama at Birmingham

Birmingham, United States, 35243

Status
Terminated
 
Locations

University of Virginia Health System

Charlottesville, United States, 22908

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Completed
 
Locations

University of Louisville

Louisville, United States, 40202

Status
Completed
 
Locations

Rush University Medical Center

Chicago, United States, 60612

Status
Terminated
 
Locations

Mountainside Hospital

Montclair, United States, 07042

Status
Completed
 
Locations

Oncology Specialists, SC

Park Ridge, United States, 60068

Status
Terminated
 
Locations

Advocate Lutheran General Hospital

Park Ridge, United States, 60068

Status
Terminated
 
Locations

Hôpital Ambroise Paré - Boulogne Billancourt

BOULOGNE-BILLANCOURT, France, 92104

Status
Completed
 
Locations

Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

Status
Completed
 
Locations

Hôpital de la Pitié-Salpétrière - Paris

PARIS, France, 75634

Status
Terminated
 
Locations

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, Germany, 54290

Status
Terminated
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69112

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Completed
 
Locations

Universitätsklinikum des Saarlandes

Homburg, Germany, 66421

Status
Completed
 
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

St James' University Hospital

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
Locations

Vanderbilt University Medical School

Nashville, United States, 37232-6307

Status
Completed
 
Locations

Memorial Sloan-Kettering Cancer Center

New York, United States, 10065

Status
Completed
 
Locations

The Angeles Clinic & Research Institute

Los Angeles, United States, 90025

Status
Completed
 
Locations

James Care - Kenny Road

Columbus, United States, 43221

Status
Completed
 
Locations

Hôpital Saint André - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Erasmus MC Daniel den Hoed

ROTTERDAM, Netherlands, 3075 EA

Status
Completed
 
Locations

Nederlands Kanker Instituut

AMSTERDAM, Netherlands, 1066 CX

Status
Completed
 
Locations

Cabrini Medical Centre

Malvern, Australia, 3144

Status
Completed
 
Locations

Royal Prince Alfred Hospital

Camperdown, Australia, 2050

Status
Terminated
 
Locations

The Alfred Hospital

Melbourne, Australia, 3004

Status
Completed
 
Locations

Newcastle Mater Misericordiae Hospital

Warartah, Australia, 2300

Status
Completed
 
Locations

Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

Status
Terminated
 
Locations

University of South Florida

Tampa, United States, 33612

Status
Completed
 
Locations

University of Colorado Health Sciences Center

Aurora, United States, 80045

Status
Completed
 
Locations

Seattle Cancer Care Alliance

Seattle, United States, 98109-1023

Status
Completed
 
Locations

Roswell Park Cancer Institute

Buffalo, United States, 14263

Status
Completed
 
Locations

Centre Val d'Aurelle - Montpellier

MONTPELLIER CEDEX, France, 34298

Status
Terminated
 
Locations

Hôpital Saint Louis - Paris

PARIS, France, 75010

Status
Completed
 
Locations

Hôpital Morvan - Brest

BREST, France, 29285

Status
Completed
 
Locations

Centre Léon Bérard

LYON CEDEX, France, 39373

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Princess Margaret Hospital-University Health Network

Toronto, Canada, M5G 2M9

Status
Completed
 
Locations

London Regional Cancer Program

London, Canada, N6A 4L6

Status
Completed
 
Locations

Tom Baker Cancer Centre

Calgary, Canada, T2N 4N2

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

University Medical Center Utrecht

UTRECHT, Netherlands, 3584 CX

Status
Terminated
 
Locations

Austin Health

Heidelberg, Australia, 3084

Status
Completed
 
Locations

Westmead Hospital

Westmead, Australia, 2145

Status
Completed
 
Locations

Brisbane Mater Misericordiae Hospital

Brisbane, Australia, 4101

Status
Completed
 
Locations

Peter MacCallum Cancer Institute

East Melbourne, Australia, 3002

Status
Completed
 

Trial Design