To determine the activity and @entity137 of @entity136 in @entity1149 , three phase II studies of single agent @entity136 have been conducted between 1990 and 1994. In an early phase II study, @entity136 was administered of 800 mg/m2 on day 1, 8, 15 every four weeks (step I), and 1,000 mg/m2 (step II). Response was observed in 3 of 13 @entity1 with previously untreated @entity1149 , although there was no responders in the previously treated @entity1 . Late phase II studies were performed at 20 (group A) and 24 (group B) Japanese institutions to confirm the efficacy and safety of @entity136 administered alone in @entity1 with @entity1149 . Seventy-three @entity1 (group A) and 67 @entity1 (group B) were entered into these studies. All @entity1 had no previous chemotherapy and had measurable disease. @entity136 was administered at a starting dose of 1,000 mg/m2/wk for 3 weeks followed by a week of rest. The dose was escalated to 1,250 mg/m2 if severe @entity137 was not seen in the previous course. Nineteen of 73 @entity1 (26%) had a partial response in group A. Of 67 @entity1 , 14 (20.9%) showed a partial response in group B. Grade 3 or greater @entity137 included @entity417 (20.5%) and @entity1431 (9.6%) in group A, and in 13.4% and seven 10.4% in group B, respectively. And grade 3 @entity882 was observed in 1.4%. Other @entity137 including hepatic @entity137 , @entity1295 , @entity390 / @entity391 , and @entity221 were mild and transient. @entity358 was observed in five @entity1 , two of whom died of @entity649 . The median durations of response were 19.6 weeks in group A and 20 weeks in group B, and median survival times were 44 and 39 weeks, respectively. In conclusion, @entity136 is an active agent against @entity1149 with very mild @entity137 . These results suggest that @entity136 has potential utility in advanced @entity1149 on an outpatient basis. Further trials in combination with other active agents are warranted.

[Phase II studies of @entity136 for XXXX in Japan].

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity417 :: ('MESH:D000740', 'Disease') :: ['anemia'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity221 :: ('MESH:D005334', 'Disease') :: ['fever'] @entity649 :: ('MESH:D012128', 'Disease') :: ['ARDS'] @entity1149 :: ('MESH:D002289', 'Disease') :: ['non-small cell lung cancer'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity358 :: ('MESH:D008171', 'Disease') :: ['Pulmonary toxicity'] @entity1431 :: ('MESH:D007970', 'Disease') :: ['leukopenia'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine']
@entity1149 :: (MESH:D002289,Disease) :: ['non-small cell lung cancer']
