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

Condition	Treatment or Intervention	Phase
Renal Cell Carcinoma	Drug: SU011248	Phase II

Further Study Details: 

Expected Total Enrollment:  100

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

Criteria

• Histologically proven renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease by radiographic technique
• Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy (IL-2, IFN, or IL-2 + IFN) for at least 28 days
• Prior nephrectomy
• Male or female, 18 years or older
• ECOG performace status of 0 or 1
• Resolution of all acute toxicitites of prior therapies
• Adequate organ function
• No prior treatment with any systemic therapy other than 1 cytokine therapy
• No prior surgery, radiation, or systemic therapy within 4 weeks
• No diagnosis of a second malignancy within the last 5 years
• No known brain metastases, spinal cord compression or carcinomatous meningitis
• No known HIV or AIDs related illness
• No serious acute or chronic illness or recent history of significant cardiac abnormality
• No uncontrolled hypertension

California
      Pfizer Investigational Site, San Francisco,  California,  94115,  United States
      Pfizer Investigational Site, Duarte,  California,  91010,  United States
      Pfizer Investigational Site, Duarte,  California,  91010,  United States
Massachusetts
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States
      Pfizer Investigational Site, Boston,  Massachusetts,  02114,  United States
      Pfizer Investigational Site, Boston,  Massachusetts,  02215,  United States
      Pfizer Investigational Site, Boston,  Massachusetts,  02115,  United States
Michigan
      Pfizer Investigational Site, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      Pfizer Investigational Site, Rochester,  Minnesota,  55905,  United States
New York
      Pfizer Investigational Site, New York,  New York,  10021,  United States
      Pfizer Investigational Site, New York,  New York,  10022,  United States
North Carolina
      Pfizer Investigational Site, Durham,  North Carolina,  27705,  United States
Ohio
      Pfizer Investigational Site, Cleveland,  Ohio,  44195,  United States
Oregon
      Pfizer Investigational Site, Portland,  Oregon,  97213,  United States
Pennsylvania
      Pfizer Investigational Site, Philadelphia,  Pennsylvania,  19111,  United States
Wisconsin
      Pfizer Investigational Site, Madison,  Wisconsin,  53792,  United States

Study ID Numbers:  A6181006
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  February 13, 2004
ClinicalTrials.gov Identifier:  NCT00077974
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08