Spots Global Cancer Trial Database for A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
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Trial Identification
Brief Title: A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Official Title: An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
Study ID: NCT00864253
Conditions
Study Description
Brief Summary: The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
AZ Cancer Ctr, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
Genesis Cancer Ctr - Hot Springs, Hot Springs, Arkansas, United States
University of Arkansa for Medical Sciences, Little Rock, Arkansas, United States
Tower Cancer Research Foundation, Beverly Hills, California, United States
San Diego Pacific Oncology and Hematology Associates, Encinitas, California, United States
Loma Linda University Cancer Center, Loma Linda, California, United States
University of Southern California/Norris Cancer Center, Los Angeles, California, United States
University of CA Los Angeles, Los Angeles, California, United States
St. Mary's Medical Center, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Baptist Cancer Institute, Jacksonville, Florida, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
University of Miami Hospital and Clincs/SCCC, Miami, Florida, United States
Waren Billhartz Cancer Center, Maryville, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
IA Blood and Cancer Care, PLC, Cedar Rapids, Iowa, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Wayne State University, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Saint Louis University, Saint Louis, Missouri, United States
St. John's Medical Research, Springfield, Missouri, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
Atlantic Melanoma Center, Morristown, New Jersey, United States
Piedmont Hematology, Winston-Salem, North Carolina, United States
OH State University Arthur G. James Cancer Hospital, Columbus, Ohio, United States
Integris Cancer Institute of OK, Oklahoma City, Oklahoma, United States
St. Luke's Hospital & Health Network, Bethlehem, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Mary Crowley Research Center, Dallas, Texas, United States
Univ of TX MD Anderson Cancer Ctr, Houston, Texas, United States
Univ of TX Med School at Houston, Houston, Texas, United States
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Hope Oncology, Richardson, Texas, United States
Utah Cancer Specialist, Salt Lake City, Utah, United States
Univ. of Washington Medical Center/Seattle Cancer Care Alliance, Seattle, Washington, United States
Evergreen Hematology & Oncology, Spokane, Washington, United States
Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
Royal North Shore Hospital, Sydney, New South Wales, Australia
Sydney West Cancer Trials Centre/Westmead Hospital, Westmead, New South Wales, Australia
Royal Adelaide Hospital, Department of Medical Oncology, Adelaide, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands Perth, Western Australia, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA Centre for the Southern Interior, Kelowna, British Columbia, Canada
BCCA, Centre for the Southern Interior, Kelowna, British Columbia, Canada
BC Cancer Agency-Fraser Valley Ctr., Surrey, British Columbia, Canada
BC Cancer Agency-Vancouver, Vancouver, British Columbia, Canada
BC Cancer Agency-Vancouver Island Ctr., Victoria, British Columbia, Canada
London Regional Cancer Program, London, Ontario, Canada
Credit Valley Hospital, Missiauga, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
McGill University Dept. of Oncology Clinical Research Program, Montreal, Quebec, Canada
Hopital Saint Andre' CHU de Bordeaux, Bordeaux, , France
Centre Hospitaller Universitaire de Grenoble, Grenoble Cedex 09, , France
CHRU Hopital Claude Huriez, Lile Cedax, , France
Hopital Dypuytren-CHU de Limoges, Limoges cedex, , France
Centre Leon Berad, Lyon, , France
Hopital Sainte Marguerite, Marseille Cedex 9, , France
CHU Hopital Saint Eloi, Montepellier Cedex 5, , France
Centre Regional Val d' Aurelle Paul Lamarque, Montpellier, , France
Hopital de 1 Archet 2, Nice Cedex 3, , France
Hopital Saint-Louis, Paris Cedex, , France
Hopital Bichat, Paris, , France
Groupe hospitalier Cochin-St. Vincent de Paul, Paris, , France
Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc, Villejuif Cedex, , France
Charite Universitaetsmedizin Berlin, Berlin, BE, Germany
Universitaetsklinkum Heidelberg, Heidelberg, BW, Germany
Universitaetsklinkum Heidelberg, Heidelber, BW, Germany
Universitaetsklinkum Tuebingen, Tuebingen, BW, Germany
Universitaetsklinkum Wuerzburg PS, Wuerzburg, BY, Germany
Universitaetsklinkum Hamburg-Eppendorf, Hamburg, HH, Germany
Univeritaetsklinkum Goettingen, Gottington, NI, Germany
Medizinische Hochschuke Hannover, Hannover, NI, Germany
St. Josef-Hospital, Bochum, Northwest, Germany
Universitaetsklinkum Essen, Essen, Northwest, Germany
Universitaetklinkum Koeln, Koln, Northwest, Germany
Universitaetsklinkum Schegwig-Holstein, Keil, SH, Germany
Universitaetsklinkum Dresden, Dresden, SN, Germany
UniversitawtsklinKum Jena, Jena, Strasse 35, Germany
Universitaesklinkum Leipzig, Leipzig, , Germany
Universitaetsklinkum Mainz, Mainz, , Germany
Istituto Tumori "Giovanni Paolo II", Bari, BA, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei T, Meldola, FC, Italy
IST-Istituto Nazionale per la Ricera sul Cancro, Genova, GE, Italy
Istituto Europeo di Oncologia, Milano, MI, Italy
Istituto Nazionale Tumori, Milano, MI, Italy
IOV-Instituto Oncologico IRCCS, Padova, PD, Italy
Azienda Ospedaliera Universitaria Sense, Siena, SI, Italy
Ist. Naz. per lo studio e la cura dei tumori G. Pascale, Napoli, , Italy
Ospedale S. Chiara, Pisa, , Italy
Medisch Centrum Alkmaar, Alkmaar, , Netherlands
Rijnstate ziekenhuis Arnhem, Amhem, , Netherlands
Erasmus MC ae" Daniel den Hoed, Rotterdam, , Netherlands
H Clinic i Provincial, Barcelona, , Spain
H CLINIC I Provincial, Barcelona, , Spain
H Clinico San Carlos, Madrid, , Spain
Corporacion Sanitaria Parc Tauli, Sabadell, , Spain
Broomfield Hospital, Chelmsford, Essex, United Kingdom
Velindre Hospital, Cardiff, Glam, United Kingdom
St. George's Hospital, London, GT Lon, United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, Nott, United Kingdom
Singleton Hospital, Sothwest Wales Inst., Swansea, S Glam, United Kingdom
Univ Hospital of North Staffordshire, Stroke On Kent, Staffs, United Kingdom
Weston Park Hospital, Sheffield, Syorks, United Kingdom
Newcross Hospital, Wolverhampton, Wstmid, United Kingdom
Royal Marsden Hospital London, London, , United Kingdom
Contact Details
Name: Evan Hersh, MD
Affiliation: University of Arizona
Role: PRINCIPAL_INVESTIGATOR
Name: Ileana Elias, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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