Phase I, Open Label, Single Center, Multiple Dose, Dose Escalation Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
- Histologically confirmed adenocarcinoma of the prostate glad.
- Informed of, willing, and able to comply with, the requirements of the
investigational study and have signed a written informed consent in accordance with
institutional regulatory guidelines.
- Subjects defined as being at high risk for disease relapse based on the following
criteria: PSA > 10 ng/ml, and any one of the following: Gleason > 7 or T stage > T2b.
- Patients must have elected to and are a candidate to undergo a radical prostatectomy.
- Males greater than 18 years of age and less than or equal to 75 years of age
(physiologic) any racial/ethnic group.
- Free of significant abnormal findings as determined by screening history, physical
exam, vital signs (blood pressure, heart rate, respiration rate, and temperature),
- Performance status: ECOG < 2.
- Life expectancy of at least 5 years.
- Absolute granulocyte count > 1,500/mm3.
- Platelet count > 100,000.
- Hemoglobin > 9.0 g/dL.
- Serum calcium < 12.0 mg/dL Adequate hepatic function as evidenced by ALT and AST
values within normal range. Adequate organ function as defined by the following
criteria: Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase
[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase
[SGPT]) < 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT < 5 x
ULN if liver function abnormalities are due to underlying malignancy.
- Creatinine < 1.5 ULN.
- Patients who have stage T2a or less prostate cancer, Gleason < 6, PSA <10-ng/mL.
- Prior hormonal, surgical, radiopharmaceutical or radiation therapy, cryotherapy,
biological response modifiers, or systematic chemotherapy to treat prostatic
- Surgery within four weeks of study entry.
- Evidence of regional and/or distant metastases.
- Use of an investigational drug within 30 days prior to study entry.
- NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study
- Any of the following thing the 12 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade > 2.
- Prolonged QTc interval on baseline EKG.
- Uncontrolled Hypertension (>150/100 mm Hg despite optimal medical therapy).
- Patients receiving CYP3A4 inducers or inhibitors; patients should not take grapefruit
juice or St. John's Wort while on the study
- Known active infection.