Prostate Cancer Clinical Trial
Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer
Summary
This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy
Prior chemotherapy
Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)
History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec
Central Nervous System (CNS) involvement
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There are 23 Locations for this study
Harvey Illinois, 60426, United States
Tinley Park Illinois, 60477, United States
Hobart Indiana, 46342, United States
Munster Indiana, 46321, United States
Durham North Carolina, 27710, United States
Portland Oregon, 97239, United States
Portland Oregon, 97239, United States
Myrtle Beach South Carolina, 29572, United States
Clarksville Tennessee, 37043, United States
Franklin Tennessee, 37067, United States
Gallarin Tennessee, 37066, United States
Hermitage Tennessee, 37076, United States
Lebanon Tennessee, 37087, United States
Murfreesboro Tennessee, 37130, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37207, United States
Nashville Tennessee, 37211, United States
Smithville Tennessee, 37166, United States
Smyrna Tennessee, 37167, United States
Tullahoma Tennessee, 37388, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Madison Wisconsin, 53792, United States
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