Status:
COMPLETED
Clinical Study of SU011248 in Subjects With High Risk Prostate Cancer Who Have Elected to Undergo Radical Prostatectomy
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE1
Brief Summary
Prostate cancer is prevalent in the United States, with approximately 230,110 new cases and 29,900 deaths in 2004. Approximately 30% of new cases will be clinical stage T3 when they are diagnosed. Thi...
Eligibility Criteria
Inclusion
- 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), and urinalysis.
- 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.
Exclusion
- 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 carcinoma.
- 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 treatment.
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00790595
Start Date
June 1 2006
Last Update
July 31 2012
Active Locations (1)
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1
University of California, Los Angeles, Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095