UNASSIGNED: 4678 Background: Phase II studies suggest that the clinical activity of @entity1205 in AIPC may be increased by the addition of @entity12749 or high dose @entity3873 . We sought to test the safety of a 3-drug regimen that combined @entity1205 with @entity12749 and @entity3873 . METHODS: @entity1 with metastatic AIPC received @entity3873 60 mcg PO over 4 hours (15 mcg hourly for 4 doses) on day 1, @entity619 8 mg PO BID on days 1-3, @entity12749 280 mg PO TID on days 1-5, and @entity1205 60 mg/m(2) (70 mg/m(2) starting in cycle 2 if no >=  grade 3 @entity137 during cycle 1) IV over 60 min on day 2. Treatment was repeated every 21 days for up to 12 cycles. @entity1 received @entity117 325 mg and @entity1229 1 or 2 mg PO daily. @entity460 supplements were prohibited within 7 days of @entity3873 dosing and increased oral hydration on days 1-3 was recommended. A dose de-escalation scheme for @entity3873 was planned if dose limiting @entity137 were encountered during the first cycle of treatment in > 1/3 of @entity1 . RESULTS: 20 @entity1 were enrolled between January and October 2003. 8 @entity1 were chemotherapy-na  ve and 12 had received prior @entity1205 -based therapy (5 received more than 1 prior chemotherapy regimen). The regimen was generally well tolerated and criteria for dose de-escalation were not met. Treatment-related >=  Grade 3 @entity137 included: @entity5886 - 4, @entity221 - 2, perforated diverticulum - 1, @entity4 - 1, ALT elevation - 1, @entity417 - 1, PTT elevation -1. 3 @entity1 had @entity1031 complications and one @entity1 had grade 3 @entity811 thought to be due to @entity5 . @entity2741 was seen in 4 @entity1 (1 grade 2, 3 grade 1). 17 @entity1 are evaluable for @entity7735 response at this time. 4 of 7 chemotherapy-na  ve @entity1 (57%) met criteria for @entity7735 response (confirmed >=  50% decline). 1 of 7 @entity1 (14%) treated with 1 prior @entity1205 -containing regimen met these criteria. There were no responses among the 3 @entity1 treated with more than 1 prior chemotherapy regimen. CONCLUSIONS: High-dose @entity3873 may be safely added to @entity1205 and @entity12749 administered on a 21-day schedule. Additional studies will further define the role of this regimen in AIPC. [Table: see text].

High-Dose @entity3873 , XXXX , and @entity12749 in androgen-independent prostate cancer (AIPC): A phase I/II study.

@entity1 :: ('9606', 'Species') :: ['patient', 'Patients', 'patients'] @entity12749 :: ('MESH:D004961', 'Chemical') :: ['estramustine'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities', 'toxicity'] @entity7735 :: ('MESH:C563250', 'Disease') :: ['PSA'] @entity417 :: ('MESH:D000740', 'Disease') :: ['anemia'] @entity2741 :: ('MESH:D006934', 'Disease') :: ['Hypercalcemia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity3873 :: ('MESH:D002117', 'Chemical') :: ['calcitriol'] @entity117 :: ('MESH:D001241', 'Chemical') :: ['aspirin'] @entity221 :: ('MESH:D005334', 'Disease') :: ['Neutropenic fever'] @entity4 :: ('MESH:D004487', 'Disease') :: ['edema - 1, vomiting'] @entity5886 :: ('MESH:D017674', 'Disease') :: ['Hypophosphatemia'] @entity619 :: ('MESH:D003907', 'Chemical') :: ['dexamethasone'] @entity1031 :: ('MESH:D013923', 'Disease') :: ['thromboembolic'] @entity460 :: ('MESH:D002118', 'Chemical') :: ['Calcium'] @entity811 :: ('MESH:D006417', 'Disease') :: ['hematuria'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel'] @entity1229 :: ('MESH:D014859', 'Chemical') :: ['warfarin']
@entity1205 :: (MESH:C067311,Chemical) :: ['docetaxel']
