The objectives of this study are: 1) to characterize the safety profile of one cycle of oral OXi-104 in combination with cisplatin in patients with solid tumors who have failed standard therapy or for whom no standard therapy exists. 2) to characterize the safety profile of multiple cycles of oral OXi-104 in combination with cisplatin. 3) to evaluate the pharmacokinetic profile of oral OXi-104 in combination with cisplatin in this population. 4) to determine the recommended dose of the combination of OXi-104 and cisplatin for future studies. 5) to document any antitumor activity of OXi-104 in combination with cisplatin in this population. This is a Phase I, open-label, dose-escalating study of OXi-104 in patients with solid tumors who have failed standard therapy or for whom no such therapy exists. Up to 50 patients will be enrolled (at all sites) into increasing dose levels to assess the safety of OXi-104 in combination with cisplatin. Patients will receive OXi-104 orally on days 1 to 3 of each 28-day cycle. In addition, on day 2 of each cycle, patients will receive intravenous cisplatin 30 minutes after taking OXi-104. Blood and urine samples will be collected during cycle 1 at each dose level to characterize the pharmacokinetics of OXi-104.

Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
37
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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