OBJECTIVES:: @entity151 ( @entity151 ) has limited treatment options. @entity8253 and @entity786 have shown synergy in many @entity5 . @entity12418 (AMR) and @entity786 both have single-agent activity in @entity151 . This phase I trial evaluated the combination of AMR and @entity786 in refractory solid organ malignancies and in relapsed @entity151 . MATERIALS AND METHODS:: The primary endpoint was to determine maximum-tolerated dose and dose-limiting @entity137 of the combination. Eligible @entity1 were enrolled in sequential dose escalation cohorts in a standard 3+3 design. Treatment consisted of cyclophosphamide IV at 500 mg/m on day 1 with escalating doses of AMR IV on days 1 to 3 (25 to 40 mg/m with increments of 5 mg/m per cohort). Cycles were repeated every 21 days. Exploratory objectives analyzed the presence of @entity5878 polymorphisms and topoisomerase IIA amplification and correlation with response. RESULTS:: Thirty-six @entity1 were enrolled, of whom 18 @entity1 had @entity151 (50%). Maximum-tolerated dose was determined to be dose level 2 ( @entity786 500 mg/m, AMR 30 mg/m) due to grade 4 @entity882 . The main grade 3 to 4 @entity137 were hematologic. Efficacy results are available for 34 @entity1 . Partial responses, stable disease, and progressive disease rates in the overall study population were 20.6% (n=7), 38.2% (n=13), and 41.2% (n=14), respectively. Partial response, stable disease, and progressive disease rates in the @entity151 @entity1 and 1 @entity1 with extrathoracic small cell were 36.8% (n=7), 26.3% (n=5), and 36.8% (n=7), respectively. There was no correlation between topoisomerase IIA amplification or @entity5878 polymorphisms and response. CONCLUSIONS:: AMR and @entity786 can be safely combined with little activity observed in heavily pretreated @entity151 @entity1 .

Phase I Study of @entity12418 and @entity786 in XXXX With Advanced Solid Organ Malignancies: HOG LUN 07-130.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity12418 :: ('MESH:C055866', 'Chemical') :: ['Amrubicin'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities'] @entity8253 :: ('MESH:D018943', 'Chemical') :: ['Anthracyclines'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumors'] @entity786 :: ('MESH:D003520', 'Chemical') :: ['cyclophosphamide'] @entity5878 :: ('1728', 'Gene') :: ['NQO1'] @entity151 :: ('MESH:D055752', 'Disease') :: ['SCLC', 'Relapsed small cell lung cancer']
@entity1 :: (9606,Species) :: ['Patients']
