OBJECTIVES: The primary objective was to evaluate the clinical efficacy of hu3S193, a humanized monoclonal antibody against the Lewis-Y antigen, in @entity1 with platinum resistant/refractory @entity43 . Secondary objectives were safety and pharmacokinetics. In addition, we sought to determine the potential interaction of clinical benefit and @entity1 characteristics. METHODS: This two-stage, multicenter, single arm, phase II trial enrolled eligible @entity1 to receive hu3S193 weekly at a dose of 20mg/m(2) intravenously for 8 weeks (1 cycle) to a maximum of 3 cycles. Efficacy was measured as clinical benefit rate (objective response or stable disease for at least 24 weeks). RESULTS: 26 of 31 @entity1 were eligible for efficacy analysis. No complete/partial responses were observed. Six @entity1 had stable disease for 24+weeks [clinical benefit rate 23% (95% CI=9.77%-46.71%)]. Median PFS was 8.4 weeks (95% CI=6.0 to 16.1). Median PFS differed between @entity1 with no ascites and no visceral disease and @entity1 with ascites and/or visceral disease [16.1 vs. 8.1 weeks (p=0.0058)]. The most commonly reported treatment-related adverse events were fatigue (19.3%) and nausea (16.2%). Allergic reactions occurred in 6 @entity1 (5 with Grade 1/2; 1 with Grade 3). CONCLUSIONS: Hu3S193 lacked sufficient activity in the first stage of the study to open enrollment to the second stage. However, based on the longer PFS in @entity1 with no ascites and no visceral disease, consolidation strategies in platinum sensitive disease are currently being tested.

A phase II trial with anti-Lewis-Y monoclonal antibody (hu3S193) for the treatment of platinum resistant/refractory XXXX .

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity43 :: ('MESH:D010051', 'Disease') :: ['ovarian, fallopian tube and primary peritoneal carcinoma']
@entity43 :: (MESH:D010051,Disease) :: ['ovarian, fallopian tube and primary peritoneal carcinoma']
