PURPOSE: @entity136 has shown a broad range of activity in solid @entity5 , including previously untreated @entity151 ( @entity151 ). The objective of this phase II trial was to investigate the activity of @entity136 in @entity1 with relapsed @entity151 . @entity1 AND METHODS: @entity151 @entity1 with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible. @entity1 were required to have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and adequate organ function; signed informed consent was also required. Treatment consisted of @entity136 1,000 mg/m2 on days 1, 8, and 15 of a 28-day cycle. @entity1 were stratified according to their previous response to first-line chemotherapy (primary refractory v primary sensitive disease). RESULTS: Forty-six @entity1 were enrolled onto this phase II trial (20 refractory and 26 sensitive @entity1 ). Forty-two of these @entity1 were assessable for response and survival, and 44 were assessable for @entity137 . Median @entity1 age was 60 years, and median ECOG performance status was 1. Principal grade 3/4 hematologic @entity137 included @entity1398 (27%) and @entity882 (27%). The main grade 3/4 nonhematologic @entity137 were pulmonary (9%) and neurologic @entity137 (14%). Objective responses occurred in 11.9% of @entity1 overall, including one @entity1 with refractory @entity151 (5.6%) and four @entity1 with sensitive @entity151 (16.7%). Median survival for the overall group was 7.1 months. Survival was not significantly different for @entity1 with refractory versus sensitive disease. CONCLUSION: @entity136 has modest activity in previously treated @entity151 @entity1 . The favorable @entity137 profile warrants further investigation, either in combination chemotherapy regimens or with targeted biologic compounds.

Phase II trial of XXXX in refractory or relapsed @entity151 : Eastern Cooperative Oncology Group Trial 1597.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumors'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity151 :: ('MESH:D055752', 'Disease') :: ['SCLC', 'small-cell lung cancer'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine']
@entity136 :: (MESH:C056507,Chemical) :: ['gemcitabine']
