The purpose of this study is to test whether SU011248 has activity and is safe compared to Interferon-alfa in patients with metastatic Renal Cell Carcinoma (RCC).

Condition	Treatment or Intervention	Phase
Renal Cell Carcinoma	Drug: SU011248  Drug: Interferon-alfa	Phase III

Further Study Details: 

Expected Total Enrollment:  690

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

Criteria

Inclusion Criteria:

• Histologically confirmed renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease by radiographic technique
• Male or female, 18 years or older
• ECOG performance status of 0 or 1
• Resolution of all acute toxicities of prior therapies
• Adequate organ function

Exclusion Criteria:

• Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
• Major surgery or radiation therapy within 4 weeks
• Severe hemorrhage within 4 weeks
• Diagnosis of a second malignancy within the last 5 years
• History of or known brain metastases, spinal cord compression or carcinomatous meningitis
• Serious acute or chronic illness or recent history of significant cardiac abnormality
• Pre-existing thyroid abnormality with thyroid function that cannot be controlled by medication
• Known HIV or AIDS-related illness
• Current treatment on another clinical trial

SU011248 Clinical Trial Information Service:      877-416-6248 
[NEW LOCATIONS ARE UPDATED TO THIS WEBSITE MONTHLY...... FOR MORE CURRENT INFORMATION, PLEASE CALL THE NUMBER LISTED.]    

California
      Pfizer Investigational Site, San Francisco,  California,  94115,  United States; Recruiting
      Pfizer Investigational Site, La Jolla,  California,  92037,  United States; Recruiting
      Pfizer Investigational Site, Los Angeles,  California,  90095,  United States; Recruiting
      Pfizer Investigational Site, San Diego,  California,  92103,  United States; Recruiting
Colorado
      Pfizer Investigational Site, Aurora,  Colorado,  80040,  United States; Recruiting
      Pfizer Investigational Site, Denver,  Colorado,  80220,  United States; Recruiting
Florida
      Pfizer Investigational Site, Miami,  Florida,  33176,  United States; Recruiting
      Pfizer Investigational Site, Miami,  Florida,  33176,  United States; Recruiting
Illinois
      Pfizer Investigational Site, Chicago,  Illinois,  60611,  United States; Recruiting
Kansas
      Pfizer Investigational Site, Overland Park,  Kansas,  66210,  United States; Recruiting
      Pfizer Investigational Site, Kansas City,  Kansas,  66112,  United States; Recruiting
Kentucky
      Pfizer Investigational Site, Louisville,  Kentucky,  40207,  United States; Recruiting
Louisiana
      Pfizer Investigational Site, New Orleans,  Louisiana,  70115,  United States; Recruiting
      Pfizer Investigational Site, Metairie,  Louisiana,  70006,  United States; Recruiting
      Pfizer Investigational Site, Chalmette,  Louisiana,  70043,  United States; Recruiting
      Pfizer Investigational Site, Metairie,  Louisiana,  70002,  United States; Recruiting
      Pfizer Investigational Site, Covington,  Louisiana,  70433,  United States; Recruiting
Maryland
      Pfizer Investigational Site, Baltimore,  Maryland,  21287,  United States; Recruiting
Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States; Recruiting
      Pfizer Investigational Site, Boston,  Massachusetts,  02114,  United States; Recruiting
Minnesota
      Pfizer Investigational Site, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Mississippi
      Pfizer Investigational Site, Southaven,  Mississippi,  38671,  United States; Recruiting
      Pfizer Investigational Site, Columbus,  Mississippi,  39705,  United States; Recruiting
      Pfizer Investigational Site, Corinth,  Mississippi,  38834,  United States; Recruiting
      Pfizer Investigational Site, Tupelo,  Mississippi,  38801,  United States; Recruiting
Missouri
      Pfizer Investigational Site, Kansas City,  Missouri,  64111,  United States; Recruiting
      Pfizer Investigational Site, Lee Summit,  Missouri,  64064,  United States; Recruiting
      Pfizer Investigational Site, Kansas City,  Missouri,  64154,  United States; Recruiting
      Pfizer Investigational Site, Kansas City,  Missouri,  66112,  United States; Recruiting
Nebraska
      Pfizer Investigational Site, Omaha,  Nebraska,  68198,  United States; Recruiting
New Hampshire
      Pfizer Investigational Site, Lebanon,  New Hampshire,  03756,  United States; Recruiting
New York
      Pfizer Investigational Site, New York,  New York,  10022,  United States; Recruiting
      Pfizer Investigational Site, New York,  New York,  10021,  United States; Recruiting
      Pfizer Investigational Site, New York,  New York,  10021,  United States; Recruiting
      Pfizer Investigational Site, Bronx,  New York,  10466,  United States; Recruiting
Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44195,  United States; Recruiting
      Pfizer Investigational Site, Cleveland,  Ohio,  44106,  United States; Recruiting
      Pfizer Investigational Site, Orange Village,  Ohio,  44122,  United States; Recruiting
      Pfizer Investigational Site, Cleveland,  Ohio,  44106,  United States; Recruiting
Oregon
      Pfizer Investigational Site, Portland,  Oregon,  97210,  United States; Recruiting
      Pfizer Investigational Site, Portland,  Oregon,  97239,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Memphis,  Tennessee,  38120,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37232,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37232,  United States; Recruiting
      Pfizer Investigational Site, Memphis,  Tennessee,  38104,  United States; Recruiting
Texas
      Pfizer Investigational Site, Dallas,  Texas,  75246,  United States; Recruiting
      Pfizer Investigational Site, Tyler,  Texas,  75702,  United States; Recruiting
      Pfizer Investigational Site, Houston,  Texas,  77030,  United States; Recruiting
Utah
      Pfizer Investigational Site, Salt Lake City,  Utah,  84112,  United States; Recruiting
Washington
      Pfizer Investigational Site, Seattle,  Washington,  98101,  United States; Recruiting
      Pfizer Investigational Site, Seattle,  Washington,  98109,  United States; Recruiting
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53792,  United States; Recruiting
Australia
      Pfizer Investigational Site, Victoria,  36184,  Australia; Recruiting
Australia, Queensland
      Pfizer Investigational Site, South Brisbane,  Queensland,  4101,  Australia; Recruiting
Australia, South Australia
      Pfizer Investigational Site, Woodville South,  South Australia,  5011,  Australia; Recruiting
Australia, Victoria
      Pfizer Investigational Site, East Melbourne,  Victoria,  3002,  Australia; Recruiting
Canada
      Pfizer Investigational Site, Quebec,  G1S 2L6,  Canada; Recruiting
      Pfizer Investigational Site, Quebec,  G1R 2J6,  Canada; Recruiting
Canada, Alberta
      Pfizer Investigational Site, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
      Pfizer Investigational Site, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Canada, British Columbia
      Pfizer Investigational Site, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Terminated
      Pfizer Investigational Site, Victoria,  British Columbia,  V5Z 4E6,  Canada; Recruiting
      Pfizer Investigational Site, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Recruiting
      Pfizer Investigational Site, Kelowna,  British Columbia,  V1Y 5L3,  Canada; Recruiting
Canada, Ontario
      Pfizer Investigational Site, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
      Pfizer Investigational Site, Toronto,  Ontario,  H5G 2M9,  Canada; Recruiting
      Pfizer Investigational Site, London,  Ontario,  N6A 4L6,  Canada; Recruiting
Canada, Quebec
      Pfizer Investigational Site, Montreal,  Quebec,  H2L 4M1,  Canada; Recruiting
France
      Pfizer Investigational Site, Paris,  France; Recruiting
      Pfizer Investigational Site, Paris Cedex 13,  75651,  France; Recruiting
      Pfizer Investigational Site, Saint-Herblain,  France; Recruiting
      Pfizer Investigational Site, Lyon,  France; Recruiting
Italy
      Pfizer Investigational Site, Roma,  00144,  Italy; Recruiting
      Pfizer Investigational Site, Pavia,  Italy; Recruiting
      Pfizer Investigational Site, Roma,  00144,  Italy; Recruiting
Poland
      Pfizer Investigational Site, Warsaw,  Poland; Recruiting
      Pfizer Investigational Site, Gdansk,  Poland; Recruiting
      Pfizer Investigational Site, Wroclaw,  50079,  Poland; Recruiting
      Pfizer Investigational Site, Lublin,  20090,  Poland; Recruiting
      Pfizer Investigational Site, Poznan,  Poland; Recruiting
Poland, Warszawa
      Pfizer Investigational Site, Moczowego,  Warszawa,  Poland; Recruiting
Spain
      Pfizer Investigational Site, Barcelona,  Spain; Recruiting
Spain, Navarra
      Pfizer Investigational Site, Pamplona,  Navarra,  Spain; Recruiting

Study ID Numbers:  A6181034
Record last reviewed:  March 2005
Last Updated:  March 15, 2005
Record first received:  June 3, 2004
ClinicalTrials.gov Identifier:  NCT00083889
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08