Finding studies
Finding studies
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Lead
Wake Forest University Health Sciences
With
OBJECTIVES: * Determine the toxicity of intraperitoneal hyperthermic chemoperfusion with oxaliplatin in patients with stage IV peritoneal surface malignancies from primary colorectal or appendiceal cancer. * Determine the pharmacokinetics of this drug in perfusate, normal peritoneum, and peritoneal surface tumors in these patients. * Evaluate the expression of proteins involved in the apoptotic and stress-inducible heat shock protein pathways (e.g., Fas, TRAIL, DISC components \[FADD, TRADD, FLIP, and caspase 8\], mitochondrial proteins \[Bax, Bak, Bcl-2, Bcl-X\_L\], and heat shock proteins \[HSPs 27, 40, 70 and 90\]) before and after drug therapy. OUTLINE: This is a nonrandomized, open-label, dose-escalation study. Patients undergo gross tumor resection on day 1. After tumor debulking, patients receive oxaliplatin over 2 hours by intraperitoneal hyperthermic chemotherapy (IPHC). Cohorts of 3-6 patients in each stratum receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. Patients undergo blood and tissue sampling before and after IPHC for pharmacokinetic studies and for evaluation of proteins involved in apoptosis and heat-shock-mediated cell death (e.g., Fas, TRAIL, FADD, TRADD, FLIP, caspase 8, Bax, Bak, Bcl-X, and heat shock proteins 27, 40, 70, and 90). After completion of study treatment, patients are followed periodically for at least 1 year. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
