PURPOSE: We conducted a randomised phase II study to assess the safety and efficacy of standard versus high-dose pemetrexed in @entity902 -resistant @entity43 (PR-EOC). The expression of ten genes was also examined as potential biomarkers of pemetrexed/ @entity902 activity. @entity1 AND METHODS: @entity1 received pemetrexed 500mg/m(2) (Pem500) or 900mg/m(2) ( @entity27475 900) on day 1 of each 21-d cycle. Responses were defined per RECIST for measurable disease or by Gynaecologic Cancer Intergroup (GCIG) CA-125 criteria for non-measurable disease. RESULTS: Of 102 @entity1 randomised, 98 were evaluable for @entity137 (47 Pem500, 51 Pem900) and 91 were evaluable for efficacy (43 Pem500, 48 Pem900) of whom 68 had measurable disease and 23 had @entity66 . The overall RR was 9.3% (95% CI: 2.6-22.1%) on Pem500 and 10.4% (95% CI: 3.5-22.7%) on Pem900. The median progression-free survival (PFS) was 2.8 months on both arms, and the median survival was 11.9 and 10.3 months, respectively. Lower mRNA expression of @entity11833 ( @entity11833 ) and reduced folate carrier 1 (RFC1) were associated with longer PFS and time to treatment failure, respectively. Grade 3/4 @entity137 , including fatigue, @entity390 and @entity391 , were numerically greater on Pem900. Pemetrexed-related SAEs occurred in 17% and 28% of Pem500 and Pem900 @entity1 , respectively. CONCLUSIONS: Pemetrexed has activity in PR-EOC equivalent to other agents in @entity902 -resistant disease; however, Pem500 has the preferable @entity137 profile. @entity11833 and RFC1 may merit examination as predictive biomarkers in PR-EOC.

A randomised, double-blind, phase II study of two doses of pemetrexed in the treatment of XXXX -resistant, epithelial ovarian or primary peritoneal cancer.

@entity43 :: ('MESH:D010051', 'Disease') :: ['epithelial ovarian cancer'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity11833 :: ('2067', 'Gene') :: ['ERCC1', 'excision repair cross-complementation group 1'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity66 :: ('MESH:D004194', 'Disease') :: ['CA-125-defined disease'] @entity391 :: ('MESH:D014839', 'Disease') :: ['vomiting'] @entity27475 :: ('CHEBI:53221', 'Chemical') :: ['Pem'] @entity902 :: ('MESH:D010984', 'Chemical') :: ['platinum']
@entity902 :: (MESH:D010984,Chemical) :: ['platinum']
