Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
Condition: Carcinoma, Renal Cell Metastasis
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: SU011248 (sunitinib)
Intervention description: 37.5 mg/day, oral, continuous daily dosing
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the anti-tumor activity of SU011248 (sunitinib) in cytokine-refractory metastatic
      renal cell carcinoma (RCC) when administered in a continuous treatment regimen
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven renal cell carcinoma with metastases.

          -  Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in
             Solid Tumors (RECIST).

          -  Failure of 1 prior cytokine-based therapy for metastatic disease. Patients treated
             with IFN-á alone must have received IFN-á for at least 4 weeks.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

          -  Resolution of all acute toxic effects of prior therapy or surgical procedures to grade
             1.

          -  Adequate organ function

        Exclusion Criteria:

          -  Prior treatment with any systemic therapy other than 1 cytokine-based therapy.

          -  Previous treatment on a SU011248 (sunitinib) clinical trial.

          -  Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the
             study treatment.

          -  Diagnosis of any second malignancy within the last 3 years, except basal cell
             carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately
             treated with no evidence of recurrent disease for 12 months.

          -  History of or known brain metastases, spinal cord compression, or carcinomatous
             meningitis, or new evidence of brain or leptomeningeal disease on screening Computed
             Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.

          -  Any of the following within the 12 months prior to starting the study treatment:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, congestive heart failure, cerebrovascular accident or transient ischemic
             attack, or pulmonary embolism.

          -  Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc
             interval >450 msec for males or >470 msec for females.

          -  Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal
             medical therapy).

          -  Ongoing treatment with therapeutic doses of Coumadin (however, low dose Coumadin up to
             2 mg PO daily for deep vein thrombosis prophylaxis is allowed).

          -  Known human immunodeficiency virus (HIV) infection.