Conditions: Prostatic Neoplasms
Keywords: First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 93
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: SU011248 in combination with docetaxel and prednisone

Interventions: intervention 1: Docetaxel intervention 2: Prednisone intervention 3: SU011248
Intervention descriptions: intervention 1: 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). intervention 2: Prednisone Phase1/2 - 5 mg twice a day (BID), oral. intervention 3: 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).

Protocol document: