Pemetrexed and XXXX for biliary tract and @entity1086 : a North Central Cancer Treatment Group (NCCTG) phase I and II Trial, N9943.

@entity1 @entity1501 @entity2186 @entity1398 @entity1086 @entity136 @entity1125
PURPOSE: To determine the maximum tolerated dose (MTD) and efficacy of pemetrexed and @entity136 in @entity1 with either biliary tract or @entity1086 . @entity1 AND METHODS: @entity1 with unresectable previously untreated @entity1125 were eligible for participation. An initial phase I trial was performed to determine the MTD using an every-2-weeks schedule. The MTD was then used in the phase II portion of the trial. The primary end point for the phase II portion was 6-month survival with a planned accrual of 59 @entity1 . RESULTS: Overall, 63 eligible @entity1 were enrolled. The MTD was established as pemetrexed 500 mg/m2 IV over 10 min and @entity136 800 mg/m2 IV at 10 mg/m2 per minute on days 1 and 15 of an every-4-weeks schedule with @entity2186 and @entity1501 supplementation. Fifty-eight @entity1 were included in the phase II portion. Median age was 61 and median follow-up was 18.2 months. A median of three cycles of treatment was given. Six-month survival was 55% and the median survival was 6.6 months (95% confidence interval 5.4-8.7 months) with a median time to progression of 3.8 months (2.4-5.4). Forty-seven (81%) experienced at least one grade 3+ adverse event, and 28 @entity1 (48%) experienced at least one grade 4 adverse event, most of which were due to grade 4 @entity1398 . CONCLUSION: The addition of pemetrexed to fixed-dose-rate @entity136 , in a biweekly schedule, did not enhance the activity of @entity136 in @entity1 with biliary tract or @entity1086 .
