UNASSIGNED: 7287 Background:This phase I/II study of @entity3003 (C) and weekly @entity1311 (P) for advanced @entity1149 ( @entity1149 ) aimed to determine maximum tolerated dose (MTD) and dose limiting @entity137 (DLT) and to evaluate the efficacy and the feasibility of this regimen. METHODS: Eligible @entity1 (pts) had no prior chemotherapy, were 20-74 years old, PS 0-2, and had adequate organ functions. C was administered on day 1, while P was administered on days 1, 8, 15 on a schedule of 28 days. The initial dose was AUC=5 for C and 60mg/m(2) for P. The dose for the second level was escalated by AUC=6 for C, while the dose of P was increased in increments of 10 mg/m(2) up to 100 mg/m(2)(6 levels). DLT was defined as G4 @entity1398 over 4 days, @entity1398 , G4 @entity882 , @entity1503 G3,depends on document reviewtreatment delay more than 3 weeks, or treatment refusal by pt during the study. MTD was defined when the incidence of DLT exceeds 33.3% at each dose level. RESULTS: A total of 26 pts were enrolled and were evaluable for @entity137 and response. The 26 pts received a total of 61 cycles of treatment. @entity1 characteristics were as follows: male/female: 24/2, median age: 59.2(37-72), PS 0-1/2: 25/1, Ad/Sq: 17/9, stage IIIA/IIIB/IV: 1/9/16. The MTD was estimated to be 100 mg/m(2) since G3 infection as DLT occurred in 2 pts at level 6 (P 100 mg/m(2)). No DLT except for G3 infection was observed through the study, and @entity1398 , @entity16 and @entity925 were mild. G4 @entity1398 occurred in only 7.9% of the 61 cycles. No @entity1398 or G4 @entity882 were observed. G1/G2 @entity16 occurred in only 6.3%/6% and G1/G2 @entity925 occurred in only 4.8%/0%, respectively. The delivery rate of P was 98.4% for the total of 61 cycles (183 doses). All cycles were completed up to level 5. The response rate was 50.0% with PR in 13 pts. CONCLUSIONS: These results showed that the combination of C and weekly P is feasible and effective for advanced @entity1149 . Especially, this combination schedule may reduce @entity1398 , @entity16 and @entity925 more markedly than the standard schedule of C and P. C AUC=6 and P 80-90mg/m(2) should be recommended for a randomized study in order to confirm these promising findings. No significant financial relationships to disclose.

Phase I/II study of @entity3003 and weekly XXXX for advanced @entity1149 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity16 :: ('MESH:D009422', 'Disease') :: ['neuropathy'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small cell lung cancer'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity1503 :: ('MESH:D006402', 'Disease') :: ['non-hematologic toxicity'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia', 'G3 febrile neutropenia'] @entity925 :: ('MESH:D063806', 'Disease') :: ['myalgia']
@entity1311 :: (MESH:D017239,Chemical) :: ['paclitaxel']
