OBJECTIVES: Few effective options are available for the treatment of unresectable @entity157 ( @entity157 ). Several phase I trials suggest promising activity of a combination of @entity136 and @entity1205 . METHODS: @entity1 with unresectable or metastatic @entity157 were treated with @entity1205 40 mg/m (later reduced to 30 mg/m) and @entity136 800 mg/m on days 1 and 8 every 3 weeks. Twenty-five @entity1 were enrolled in 26 months. Median age was 64 (range, 27-078), 17 were male, 14 had @entity409 , and 11 had @entity6687 . RESULTS: Of 25 @entity1 evaluable for the primary end point (response), 2 (8%) have a confirmed partial response. The median time to progression is 2.76 months (95% confidence interval, 1.84-6.64 mo). Median survival was 12.8 months (95% confidence interval, 5.26-28.00). Two @entity1 died on study owing to adverse events (1 hepatic and 1 @entity177 ), neither of which were attributed to the study medications. Twenty @entity1 (81%) have experienced grade 3+ adverse events, including 11 with grade 4+ adverse events, primarily @entity1398 , @entity882 , @entity294 , and @entity1295 . CONCLUSIONS: Although this combination seems to have potential benefit, as measured by overall survival, its @entity137 and the recent introduction of @entity2857 has further limited the use of chemotherapy. Approaches other than chemotherapy are likely to be of the greatest potential benefit.

XXXX and @entity1205 for @entity157 : a phase II North Central Cancer Treatment Group clinical trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity409 :: ('MESH:D008107', 'Disease') :: ['liver-only disease'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity2857 :: ('MESH:C471405', 'Chemical') :: ['sorafenib'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity177 :: ('MESH:D051437', 'Disease') :: ['renal failure'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity6687 :: ('MESH:D001651', 'Disease') :: ['extrahepatic disease'] @entity157 :: ('MESH:D006528', 'Disease') :: ['HCC', 'hepatocellular carcinoma'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['docetaxel']
@entity136 :: (MESH:C056507,Chemical) :: ['Gemcitabine']
