SCH 58500 is a novel agent for treating cancer and is a recombinant replication deficient adenovirus capable of directing expression of wild-type p53 protein from a copy of p53 cDNA. This is an open label, randomized, two arm, multi center Phase II trial to be conducted worldwide. Patients with colorectal cancer who have failed no more than two prior systemic chemotherapy regimen and have metastatic liver disease for which they have received no prior liver directed therapy will undergo surgical placement of an indwelling hepatic artery pump. Once patients have recovered from surgery they will be randomized to receive SCH58500 plus IHA FUDR, or IHA FUDR alone for up to 5 cycles. A data monitoring committee(DMC) will review the data during the trial and make recommendations regarding dose reductions for safety and discontinuation of the trial for safety and the absence of efficacy.
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