The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in
locally advanced or metastatic renal cell cancer and to evaluate the safety profile of
CP-461 in this patient population.
1. Measurable metastatic or locally advanced disease.
2. Histologically confirmed renal cell cancer.
3. 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.
4. Expected remaining life span > or = three months.
5. ECOG performance status 0-2.
6. > or = 18 years of legal age.
7. Male patients, or non-pregnant and non-lactating female patients who are either using
adequate birth control, surgically sterile or post-menopausal.
8. Negative serum pregnancy test, if fertile female.
9. Willingness and ability to sign an informed consent document.
1. Uncontrolled or symptomatic brain metastases.
2. Use of an investigational medication or device within one month of initiating study
3. 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.
4. Any condition or any medication which may interfere with the conduct of the study.
5. Current active malignancy other than renal cell cancer.