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Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma

This study is currently recruiting patients.

Sponsored by: Schering-Plough
European Organization for Research and Treatment of Cancer
Information provided by: Schering-Plough

Purpose

The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.

Condition Treatment or Intervention Phase
Melanoma
  Drug: Temozolomide
 Drug: Dacarbazine
 Phase III

MedlinePlus related topics:  Melanoma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

Further Study Details: 

Expected Total Enrollment:  550

Study start: August 2004;  Study completion: November 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information


Alabama
      University of Alabama, 701 20th Street South, Birmingham,  Alabama,  35294,  United States; Not yet recruiting
Robert Conry, MD
Robert Conry, MD,  Principal Investigator

Arizona
      University of Arizona, Arizona Cancer Center, 1515 North Campbell Avenue, Room 1978, Tucson,  Arizona,  85724,  United States; Not yet recruiting
Michelle Brier  520-626-9526 
Cranmer Lee, MD,  Principal Investigator

Arkansas
      University of Arkansas Medical Center Research & Therapy, 4301 West Markham Street, Slot 508, Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
Lanette Nimmer  501-296-1502 
Laura Hutchins, MD,  Principal Investigator

Colorado
      University of Colorado Health Sciences Center, Anschutz Cancer Pavillion, Cutaneous Oncology Center, PO Box 6510, Mail Stop F703, Aurora,  Colorado,  80045,  United States; Not yet recruiting
Rene Gonzalez, MD  720-848-0564    rene.gonzalez@uchsc.edu 
Rene Gonzalez, MD,  Principal Investigator

Connecticut
      Medical Oncology & Hematology, 60 Temple Street, Suite 9C, New Haven,  Connecticut,  06510,  United States; Not yet recruiting
Leonard Farber, MD, MD  203-238-7747 
Leonard Farber, MD,  Principal Investigator

      Yale University Dept of Medicine, 333 Cedar Street, New Haven,  Connecticut,  06510,  United States; Not yet recruiting
Harriet Kluger, MD  203-389-5779    harriet.kluger@yale.edu 
Harriet Kluger, MD,  Principal Investigator

Georgia
      Emory University, 1365B Clifton Road, NE, Atlanta,  Georgia,  30322-1013,  United States; Not yet recruiting
David Lawson, MD, MD  404-778-2918    david_lawson@emory.org 
David Lawson, MD,  Principal Investigator

Indiana
      Michiana Hematology/Oncology, NICRC, 100 Navarre Place, Suite 5520, South Bend,  Indiana,  46601,  United States; Not yet recruiting
Susan Haithcox  574-647-7977    isowers@mhopc.com 
Rafat Ansari, MD,  Principal Investigator

      Indiana University Medical Center, Indiana Cancer Pavillion, 535 Barnhill Drive, Room 228, Indianapolis,  Indiana,  46202-5264,  United States; Not yet recruiting
Kristen Crowder  317-274-0792 
Theodore Logan, MD,  Principal Investigator

Iowa
      University of Iowa Hospital and Clinics, Holden Comprehensive Cancer Center, 200 Hawkins Drive, Room 5983JP, Iowa City,  Iowa,  52242,  United States; Not yet recruiting
Gill Kuennen  319-353-8775 
Gerald Clamon, MD,  Principal Investigator

Kentucky
      University of Louisville, James Graham Brown Cancer Center, 529 South Jackson Street, Louisville,  Kentucky,  40202,  United States; Not yet recruiting
Donald Miller, MD, MD  502-562-4790    donaldmi@ulh.org 
Donald Miller, MD,  Principal Investigator

Maryland
      Franklin Square Hospital, 9000 Franklin Square Drive, 2 West, Baltimore,  Maryland,  21237,  United States; Not yet recruiting
William Waterfield, MD, MD  443-777-7364    jean.m.flack@medstar.net 
William Waterfield, MD,  Principal Investigator

Michigan
      Wayne State University, Karamanos Cancer Institute, 5 Hudson, 3900 John R. Street, Detroit,  Michigan,  48201,  United States; Not yet recruiting
Larry Flaherty, MD  800-527-6266 
Larry Flaherty, MD,  Principal Investigator

Minnesota
      Park Nicollet Clinic-Saint Louis Park, 3800 Park Nicollet Blvd, St. Louis Park,  Minnesota,  55416,  United States; Not yet recruiting
Lee Martin, MD, MD  952-993-2754    leem@parknicollet.com 
Lee Martin, MD,  Principal Investigator

      Park Nicollet Institute, 2 South, St. Loius Park,  Minnesota,  55416,  United States; Recruiting
Martin Lee, MD  952-993-6071 
Martin Lee, MD,  Principal Investigator

Missouri
      Columbia Comp Cancer Care Clinic, 599 Keene Street, Medical Building Suite 202, Columbia,  Missouri,  65201,  United States; Not yet recruiting
Jeannie Chambers  573-893-6404 
Ali Khojasteh, MD,  Principal Investigator

Nebraska
      Nebraska Methodist Hospital Cancer Center, 8303 Dodge Street, Omaha,  Nebraska,  68114,  United States; Not yet recruiting
Robert Langdon, MD  402-354-5890    rlangdon@onchemwest.com 
Robert Langdon, MD,  Principal Investigator

New York
      Beth Israel Cancer Center, 10 Union Square East, Suite 4A, New York,  New York,  10003,  United States; Not yet recruiting
Ron Blum, MD, MD  212-844-8282    rblum@bethisraelny.org 
Ron Blum, MD,  Principal Investigator

      NYU-Kaplan Cancer Center, 462 First Avenue, Room 556, New York,  New York,  10016,  United States; Not yet recruiting
Anna Pavlick, MD, MD  212-263-6485    pavlia01@gcrc.med.nyu.edu 
Anna Pavlick, MD,  Principal Investigator

Pennsylvania
      University of Pittsburgh Cancer Institute, Division of Hematology/Oncology, 5150 Centre Avenue, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Sanjiv Agarwala, MD, MD  412-648-6507    agarwalass@msx.upmc.edu 
Sanjiv Agarwala, MD,  Principal Investigator

Texas
      South Texas Oncology and Hematology, Sonterra Medical Park, 155 E. Sonterra Blvd, Suite 200, San Antonio,  Texas,  78528,  United States; Not yet recruiting
Gladys Rodriguez, MD, MD  210-593-2634    esembrow@saci.rog 
Gladys Rodriguez, MD,  Principal Investigator

Utah
      Huntsman Cancer Institute, 2000 Circle of Hope Drive, Suite 2100, Salt Lake City,  Utah,  84112,  United States; Not yet recruiting
Wolfram Samlowski, MD, MD  801-581-8935    wolfram.samlowski@hci.utah.edu 
Wolfram Samlowski, MD,  Principal Investigator

Washington
      Fred Hutchinson Seattle Cancer Care Alliance, 825 Eastlake Ave East, Mail Stop G3-200, Seattle,  Washington,  98109-1023,  United States; Not yet recruiting
John Thompson, MD, MD  206-288-2044    jat@u.washington.edu 
John Thompson, MD,  Principal Investigator

Germany
      Klinikum der Stadt Mannheim, Mannheim,  D-68135,  Germany; Recruiting
Dirk Schadendorf, Professor  +49 621 3832126 
Dirk Schadendorf, Professor  +49 621 3832126 

More Information

Study ID Numbers:  P03267
Record last reviewed:  September 2004
Record first received:  September 10, 2004
ClinicalTrials.gov Identifier:  NCT00091572
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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