At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of the prostate
- ✓Progressive hormone-refractory prostate cancer (HRPC) with prior hormone treatment (orchiectomy or GnRH analog ± antiandrogen); if antiandrogen given, disease progression must be documented after discontinuation
- ✓Progressive disease defined by elevated PSA (non-measurable) or measurable disease
- ✓ECOG performance status 0 or 1
- ✕Prior thalidomide, anti-VEGF therapy, VEGF receptor inhibitor, PDGF receptor inhibitor, or anti-angiogenic treatment of any kind (including investigational)
- ✕Prior chemotherapy
- ✕Uncontrolled pain at baseline, impending bone metastasis complications (fracture/compression), or urinary obstruction (retention, hydronephrosis)
- ✕History of cardiac dysfunction or QTc >450 msec
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)
In Brief
A Phase 2 clinical trial evaluating Docetaxel, Prednisone, and 1 other intervention for Prostatic Neoplasms. Completed, enrolled 93 participants across 24 sites.
Detailed 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).
Study Details
Timeline
Interventions
Docetaxel Phase 1 - escalating doses (60 and 75 mg/m2), intravenous therapy (IV), administered every 3 weeks. Phase 2 - Phase 1 optimal combination dose (75 mg/m2, IV, every 3 weeks).
Prednisone Phase1/2 - 5 mg twice a day (BID), oral.
SU011248 Phase 1 - escalating doses (12.5, 37.5, and 50 mg), oral, administered on a 2-weeks on, 1-week off daily regimen (Schedule 2/1). Phase 2 - Phase 1 optimal combination dose (37.5 mg/day, oral, Schedule 2/1).