Abstract
3109 Background: The ubiquitinin-proteosome proteolytic pathway regulates the metabolism of critical proteins involved in the cell cycle, apoptosis and metastasis such as p53, p21, p27 and NFκB. PS341(Bortezomib; Velcade) is a specific and selective inhibitor of the 26S proteosome. PS341 results in significant regression in a human colon cancer xenograft model. Methods: This phase II study aimed to assess the activity of PS341 in patients with metastatic colorectal cancer who had received no more than 1 prior line of chemotherapy with irinotecan (or oxaliplatin)/5 fluorouracil for metastatic disease. Primary endpoints were objective response or disease stabilization; with a multinomial stopping rule and secondary endpoints included assessment of molecular changes with therapy, survival and tolerability. PS 341 at a dose of 1.3mg/m2/day was administered as an intravenous bolus days 1,4,8 and 11 of a 21 day cycle. Tumor response was assessed by RECIST criteria every 2 cycles. Tumor biopsies were performed p...
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