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.