PURPOSE: In a randomized trial, @entity1205 monotherapy yielded longer survival than the best supportive care in @entity1 with @entity1149 ( @entity1149 ) previously treated with @entity902 -based chemotherapy, and combination chemotherapy regimens containing @entity1205 have been assessed to enhance the efficacy of second-line chemotherapy. We conducted a phase I/II trial of @entity136 and @entity1205 in @entity1 with recurrent @entity1149 after @entity902 -based chemotherapy and with an ECOG performance status (PS) of 0 or 1. @entity1 AND METHODS: @entity1205 administration was fixed at a dosage of 60 mg/m(2) on day 8, and @entity136 was administered on days 1 and 8. The starting dose level of @entity136 was 800 mg/m(2) (level 0), and the subsequent dose level of @entity136 was 1000 mg/m(2) (level +1). Treatment was repeated every 3 weeks. RESULTS: In the phase I study, 13 @entity1 were enrolled, and in the phase II study, 29 @entity1 were enrolled. @entity221 and omission of treatment on day 8 due to @entity1431 (leukocyte count less than 3000/mm(3)) were dose-limiting @entity137 (DLTs). Three of six @entity1 experienced DLTs at level +1, which was the maximum tolerated dose. @entity136 800 mg/m(2) on days 1 and 8 plus @entity1205 60 mg/m(2) on day 8 (level 0) was recommended for the phase II study. An objective response was observed in 8 (28%) of the 29 @entity1 . The median time to disease progression was 4.2 months (95% CI 0.9-7.7 months). The median survival time was 11.1 months (95% CI 9.9-12.4 months), and the 1-year survival rate was 41%. The most common @entity137 , though mild, was hematologic, and consisted of grade 4 @entity1398 (18%), grade 3 @entity1398 (11%), and grade 3 @entity882 (11%). There were no toxic deaths. Grade 3 non-hematologic @entity137 included @entity390 (4%) and @entity1910 (4%). CONCLUSIONS: The combination chemotherapy of @entity136 and @entity1205 is active and well tolerated in @entity1 with recurrent @entity1149 after @entity902 -based chemotherapy and with a good PS.

Combination second-line chemotherapy with @entity136 and @entity1205 for recurrent @entity1149 after XXXX -containing chemotherapy: a phase I/II trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity902 :: ('MESH:D010984', 'Chemical') :: ['platinum'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity221 :: ('MESH:D005334', 'Disease') :: ['Neutropenic fever'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small-cell lung cancer'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel', 'Docetaxel'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia', 'febrile neutropenia'] @entity1431 :: ('MESH:D007970', 'Disease') :: ['leukopenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine']
@entity902 :: (MESH:D010984,Chemical) :: ['platinum']
