Study of CP-461 in Patients With Advanced Renal Cell Cancer

Inclusion Criteria: Measurable metastatic or locally advanced disease. Histologically confirmed renal cell cancer. No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy. Expected remaining life span > or = three months. ECOG performance status 0-2. > or = 18 years of legal age. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal. Negative serum pregnancy test, if fertile female. Willingness and ability to sign an informed consent document. Exclusion Criteria: Uncontrolled or symptomatic brain metastases. Use of an investigational medication or device within one month of initiating study therapy. Absolute granulocyte count < or = 1500/mm3; Platelet count < or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine > or = 2.2 mg/dL; AST/ALT > 2.5 ULN. Any condition or any medication which may interfere with the conduct of the study. Current active malignancy other than renal cell cancer.