PURPOSE: The primary objective of this phase I study was to determine the maximum tolerated dose for pemetrexed, alone and in combination with @entity3003 , with concurrent radiotherapy. EXPERIMENTAL DESIGN: @entity1 with locally advanced or metastatic @entity1149 ( @entity1149 ) or @entity418 were treated every 21 days for two cycles. Regimen 1 was pemetrexed (200-600 mg/m(2)); regimen 2 was pemetrexed (500 mg/m(2)) with escalating @entity3003 doses (AUC = 4-6). Both regimens included concurrent radiation (40-66 Gy; palliative-intent doses were lower). RESULTS: Thirty @entity1 (18 locally advanced and 12 metastatic with dominant local symptoms) were enrolled, with an Eastern Cooperative Oncology Group performance status of 0/1/2 (n = 8/21/1). All dose levels were tolerable for regimen 1 (n = 18: 15 @entity1149 and 3 @entity418 ) and regimen 2 (n = 12: all @entity1149 ). In regimen 1, one dose-limiting @entity137 (grade 4 @entity2910 / @entity448 ) occurred (500 mg/m(2)). Grade 3 @entity1398 (3 of 18 @entity1 ) was the main @entity1503 . In regimen 2, one dose-limiting @entity137 (grade 3 @entity2910 ) occurred (500 mg/m(2); AUC = 6); grade 3/4 @entity1431 (4 of 12 @entity1 ) was the main @entity1503 . Four complete responses (2 pathology proven) and eight partial responses were observed. When systemically active chemotherapy doses were reached, further dose escalation was discontinued, and a phase II dose-range was established (pemetrexed 500 mg/m(2) and @entity3003 AUC = 5-6). CONCLUSIONS: The combination of pemetrexed (500 mg/m(2)) and @entity3003 (AUC = 5 or 6) with concurrent radiation is well tolerated, allows for the administration of systemically active chemotherapy doses, and shows signs of activity. To further determine efficacy, safety profile, and optimal dosing, the @entity5 and @entity1778 Group B study 30407 is currently evaluating this regimen in @entity1 with unresectable stage III @entity1149 .

A phase I study of pemetrexed, @entity3003 , and concurrent radiotherapy in XXXX with locally advanced or metastatic non-small cell lung or @entity418 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity2910 :: ('MESH:D004941', 'Disease') :: ['esophagitis'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['NSCLC', 'non-small cell lung cancer'] @entity448 :: ('MESH:D000855', 'Disease') :: ['anorexia'] @entity1503 :: ('MESH:D006402', 'Disease') :: ['hematologic toxicity'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity1778 :: ('MESH:D007938', 'Disease') :: ['Leukemia'] @entity418 :: ('MESH:D004938', 'Disease') :: ['esophageal cancer', 'esophageal cancers'] @entity1431 :: ('MESH:D007970', 'Disease') :: ['leukopenia']
@entity1 :: (9606,Species) :: ['patients']
