Phase II trial of @entity1311 and @entity5537 --tegafur in XXXX . TEGATAX trial.

@entity1 @entity4181 @entity137 @entity0 @entity66 @entity4349 @entity5 @entity7273 @entity1311 @entity1398 @entity5537 @entity204 @entity1722
This Phase II trial investigated the combination @entity1311 (P) and @entity5537 -tegafur (UFT) in @entity1 with @entity0 ( @entity0 ). METHODS: Main eligibility criteria included @entity1722 negative @entity0 , ECOG performance status of 0-2, exposure to 1-2 prior chemotherapy regimen in the metastatic setting, previous exposure to an @entity4349 containing regimen either at metastatic or adjuvant setting. Each 35-day cycle consisted of P at 80  mg/m(2) by intravenous infusion on days 1, 8, 15, 22 and 29 and oral UFT at 300  mg/m(2) TID (three time a day) from days 1-28 and oral @entity4181 at 90  mg QD (one a day). RESULTS: Between March 2003 and December 2007, 31 @entity1 were enrolled. Median age was 66  years (range 44-78). All @entity5 were @entity1722 negative and 7% were triple negative (ER, @entity7273 , @entity1722 ). The majority of @entity1 had @entity66 (81%). All @entity1 had received an @entity4349 containing regimen and 74% had a previous docetaxel containing treatment. Median of 4 and 3 cycles of P and UFT were administered with a relative dose intensity of 85.3% and 94.3%, respectively. Twelve (40%)(95% CI:  22.5-57.5) confirmed ORR were observed. Stable and progression disease were reported in 43% and 17% of cases. Median Response duration was 8.4 month (95% CI: 4.9-11.7), median Time to progression was 9.5 months (95% CI: 6.6-13.8) and median Overall Survival was 23.5 months (95% CI: 16.8-37.2). Thirteen pts (43%) experienced a grade 3 or 4 adverse events (AEs): One @entity204 occurred related to the study drugs ( @entity1398 ). Chemotherapy was discontinued due to @entity137 in 30% of pts CONCLUSIONS: Accrual was closed in January 2008 due to concerns regarding the degree and accumulative nature of AEs. Nonetheless, the ORR is encouraging and warranted further studies with adapted doses and schedules.
