Services / Prostate Cancer - Untreated Advanced Tumors
Trial Information
Prostate Cancer: Clinical Trial for men with previously untreated, locally advanced tumors.
- Principal Investigator: Arie Belldegrun, M.D.
- Co-Investigators: Jean deKernion, M.D., Allan Pantuck, M.D., Robert Reiter, M.D., Matthew Rettig M.D.
This trial is currently accepting new patient applications
Objective:
Open label, phase 1, multiple dose, dose escalation clinical study of SUO11248 (sunitinib malate) in men with high risk prostate cancer who have elected to undergo radical prostatectomy.
The purpose of this study is to see if we can improve the results of surgery for patients with locally advanced prostate cancer by administering the drug sunitinib malate (SUO11248) prior to surgery.
Sunitinib may shrink the size of the tumor by blocking two basic processes of cells. These processes are called proliferation (cell division) and angiogenesis (formation of new blood vessels). This may then make the tumor easier to remove. However, there is no guarantee that this will occur.
Trial Design
SUO11248 will be administered on an outpatient basis and will be dispensed as capsules. The dose should be taken orally once daily without regard to meals. All study participants will receive treatment drugs for up to 4 weeks before surgery. Depending on time of study entry, participants will be placed in one of five groups with different doses. The dose of Sunitinib taken will be known at all times of the study.
Groups
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Intervention
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Group A: Experimental
5 Subjects will receive 37.5 mg/d of the study drug for 1 week.
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Drug: SU011248
5 Subjects will receive 37.5 mg/d of the study drug for 1 week.
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Group B: Experimental
5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
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Drug: SU011248
5 Subjects will receive 50.0 mg/d of the study drug for 1 week.
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Group C: Experimental
5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
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Drug: SU011248
5 Subjects will receive 37.5 mg/d of the study drug for 2 weeks.
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Group D: Experimental
5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.
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Drug: SU011248
5 Subjects will receive 50.0 mg/d of the study drug for 2 weeks.
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Group E: Experimental
5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.
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Drug: SU011248
5 Subjects will receive 50.0 mg/d of the study drug for 4 weeks.
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Patient Eligibility
PSA >10
Gleason grade >7 or T stage >2b
The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.
For more information
For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call recruitment coordinator Diana Sarkisyan at (310) 206-7793 (dsarkisyan@mednet.ucla.edu) or Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.
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