A Phase II Study of XXXX Combined with @entity1487 and @entity4181 (Mayo Clinic Regimen) in @entity1487 Refractory @entity14 .

@entity1 @entity901 @entity4181 @entity137 @entity390 @entity882 @entity294 @entity391 @entity16 @entity1398 @entity14 @entity204 @entity1487
PURPOSE: There are few therapeutic options in @entity1 with @entity14 that have progressed or recurred following @entity1487 ( @entity1487 ) based therapy. We evaluated the efficacy and @entity137 of @entity901 , @entity1487 , @entity4181 (Mayo clinic regimen) in @entity1487 pretreated advanced @entity14 @entity1 . MATERIALS AND METGODS: Twenty-eight @entity1 were enrolled in this study between January 1999 and May 2001. @entity1 were treated with @entity901 150 mg/m2 on day 1 as a 2-hr infusion and @entity1487 425 mg/m2, @entity4181 20 mg/m2, bolus for 5 days. Treatment courses were repeated in 4-week intervals. RESULTS: The objective response rate was 25% for 28 assessable @entity1 , all cases registered a partial response. Eleven @entity1 (39%) demonstrated stable disease, and ten (36%) progressed. The median response duration was 5.5 months, and the median time to progression was 6.3 months. The median overall survival time was 13.5 months from the start of the chemotherapy. From the 120 cycles analyzed, grade 3,4 hematologic @entity137 included @entity1398 : 1.6%, and @entity882 : 1.6%. The frequent grade 3.4 non-hematologic adverse reactions were @entity390 / @entity391 (25.0%), @entity294 (14.3%), stomititis (3.6%), and @entity16 (3.6%). There were no treatment-related @entity204 . CONCLUSION: This phase II study had relatively higher @entity137 than previous studies, and did not show an increased significant response rate. These high levels of @entity137 suggest that the study treatment combination of @entity901 with a full dose Mayo clinic regimen arm is no feasible. Therefore, this regimen will be discontinued and a safer regimen will be adopted.
