Status:
COMPLETED
Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Lead Sponsor:
Duke University
Collaborating Sponsors:
Pfizer
Conditions:
Prostate Cancer
Prostatectomy
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to look at blood and tissue samples for changes following the use of Sunitinib malate. Additionally, we would like to find out if the drug, Sunitinib malate, is safe and w...
Detailed Description
Eligible patients will be treated with 50 mg once daily for four weeks followed by one to two weeks off treatment prior to undergoing radical prostatectomy. Patients with palpable disease (cT2-3) and ...
Eligibility Criteria
Inclusion
- Histologic evidence of adenocarcinoma of the prostate deemed candidates for curative RRP
- Intermediate or high risk, clinically localized disease
- Adequate organ function
- Patients must be surgically sterile or must agree to use effective contraception during the period of therapy
- Select imaging to rule out metastasis will be done as clinically indicated
- Signed and date informed consent document
Exclusion
- Prior treatment for prostate cancer
- Major surgery or radiation therapy within 4 weeks of starting the study treatment
- NCI CTCAE grade 3 hemorrhage within 4 weeks of starting therapy
- History of or known metastatic prostate cancer
- Any of the following within the 6 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 grade 2 or greater
- QTc interval \> 500 msec on baseline EKG
- Hypertension that cannot be controlled by medications (\>150/100 mm Hg despite optimal medical therapy).
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Known active infection
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00672594
Start Date
July 1 2006
End Date
September 1 2013
Last Update
August 4 2014
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
MD Anderson, University of Texas
Houston, Texas, United States, 77030