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Title	Study of REOLYSIN® in Combination With FOLFIRI in Patients With Oxaliplatin Refractory/Intolerant KRAS Mutant Colorectal Cancer
Description	This is a Phase 1 dose-escalation study with three dose levels to determine the maximum tolerated dose of REOLYSIN combined with FOLFIRI. Reovirus Serotype 3 - Dearing Strain (REOLYSIN) is a naturally occurring, ubiquitous, non-enveloped human reovirus. Reovirus has been shown to replicate selectively in Ras-transformed cells causing cell lysis. Activating mutations in ras or mutation in oncogenes signaling through the ras pathway may occur in as many as 80% of human tumors. The specificity of the reovirus for Ras-transformed cells, coupled with its relatively nonpathogenic nature in humans, makes it an attractive anti-cancer therapy candidate.
Eligibility Criteria	To be eligible for this study, patients must meet several criteria, including but not limited to the following: * Patient must be 18 Years and older * Patient must have histologically confirmed cancer of the colon or rectum with radiologically documented and measurable metastases (high CEA alone is insufficient for study entry). * Patient must have received oxaliplatin (with or without 5-FU or capecitabine) as front-line therapy in the metastatic setting. * Patient must have a life expectancy of at least 3 months. * Patient must be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
Principal Investigator	Sanjay Goel, MD
Phone	(718) 904-2488
Contact Email	sgoel@montefiore.org
Post Date	01/07/2011
Protocol Number	10-02-037/West
Status	Recruiting
Current Trial Type	Interventional