Phase I/II trial of @entity1206 and divided-dose XXXX in advanced @entity1149 .

@entity1 @entity1665 @entity137 @entity5 @entity3003 @entity1149 @entity900 @entity1206 @entity1398 @entity2359
@entity1206 administered in a doublet with @entity900 has become a standard treatment in @entity1 with advanced @entity1149 ( @entity1149 ). However, @entity3003 appears to provide comparable efficacy with a better nonhematologic safety profile than @entity900 . Herein we report the results of a phase I/II trial of weekly @entity1206 and divided-dose @entity3003 in @entity1 with stage IIIB/IV @entity1149 , Eastern Cooperative Oncology Group performance status < or = 2, and adequate bone marrow. @entity1 received @entity1206 starting at 20 mg/m(2) (to 25 mg/m(2)) and @entity3003 area under the curve (AUC) 2.5 in divided-doses, both given on Days 1 and 8 every 21-day cycle for up to 6 cycles or until disease progression. Dose-limiting @entity137 was defined for Cycles 1 and 2. @entity5 response and @entity137 were assessed using standard criteria. Twenty-one @entity1 with a mean age of 67 years (range, 43-79) and stage IIIB/IV (8/13) disease were enrolled. All but 1 @entity1 were chemotherapy-nai;ve; the majority (n = 20) had good performance status (< or = 1). Seventy-nine courses (median, 4) were administered. The @entity1206 / @entity3003 doublet was well tolerated, with 7 courses interrupted or delayed because of @entity137 . @entity137 were generally mild and evenly divided between hematologic (i.e., @entity1398 ) and nonhematologic (i.e., fatigue). No growth factor support was required for hematologic @entity137 . There was only one case of grade 2 @entity1665 , and no cases of > or = grade 2 @entity2359 . There were 5 (24%) partial responses, and 9 (43%) @entity1 had stable disease. Weekly @entity1206 25 mg/m(2) and divided-dose @entity3003 AUC 2.5 is a well tolerated regimen with activity in advanced @entity1149 @entity1 . Further evaluation of this regimen in combination with novel targeted biologic therapy is warranted.
