Preclinical and clinical models have demonstrated that @entity3840 ( @entity3840 ) is overexpressed in primary and metastatic @entity14 . In preclinical models, there appears to be additive or synergistic effects when combining @entity1487 ( @entity1487 ) with nonsteroidal anti-inflammatory agents (NSAIDs) for the treatment of @entity14 . This data raised the question as to whether adding a @entity3840 inhibitor to @entity1487 -based regimens would increase the response rates with an acceptable @entity137 profile in @entity1 with metastatic @entity694 . In the current study, @entity1 with metastatic @entity14 , who were either untreated or previously treated (more than 1 year ago) with adjuvant @entity1487 and @entity4181 (LV) received @entity1487 and LV (Mayo regimen) in addition to @entity13586 . @entity5 samples from all @entity1 exhibited evidence of moderate @entity3840 over-expression. 4 @entity1 entered on the study developed @entity360 (grade III). Other @entity137 included grade II @entity3136 (3 @entity1 ), grade II @entity882 (1 @entity1 ), grade II @entity294 (2 @entity1 ) and grade I @entity390 (1 @entity1 ). There were no partial or complete responses in the first 10 @entity1 entered on the study so the study was terminated (probability of success < 0.3 with type 1 error of 0.05 and power of 0.8). Thus, @entity13586 did not appear to increase antitumor activity and resulted in increased @entity344 when combined with @entity1487 /LV. Future studies will need to consider the added @entity344 of @entity13586 when combined with chemotherapy for the treatment of @entity1 with @entity14 .

Increased @entity137 and lack of efficacy of XXXX in combination with chemotherapy for treatment of metastatic @entity14 : A phase II study.

@entity1 :: ('9606', 'Species') :: ['patient', 'patients'] @entity4181 :: ('MESH:D002955', 'Chemical') :: ['Leucovorin'] @entity13586 :: ('MESH:C116926', 'Chemical') :: ['Rofecoxib'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicities', 'toxicity'] @entity3136 :: ('MESH:D013280', 'Disease') :: ['stomatitis'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Tumor'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity694 :: ('MESH:D003110', 'Disease') :: ['colon cancer'] @entity344 :: ('MESH:D005767', 'Disease') :: ['gastrointestinal toxicity'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal cancer', 'colorectal neoplasms', 'colorectal tumors'] @entity3840 :: ('5743', 'Gene') :: ['COX-2', 'cyclooxygenase-2'] @entity360 :: ('MESH:D006471', 'Disease') :: ['upper gastrointestinal bleeding'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-Fluorouracil', '5-FU']
@entity13586 :: (MESH:C116926,Chemical) :: ['Rofecoxib']
