This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a single-site, phase I/II study of intraperitoneal (IP) therapy with cisplatin or carboplatin and floxuridine (FUdR) as consolidation for ovarian and gastrointestinal malignancies. The protocol arises from observations over the last 10-12 years that IP treatment of patients with ovarian cancer achieved improved loco-regional control of recurrent disease. Preliminary work by the PI at USC and at NYU validates this approach. The primary objective of the study is to assess the toxicity, tolerance and completion rate of an IP drug regimen consisting of platinum and FUdR for gynecologic or GI malignancies with minimal residual disease confined to the peritoneum. A secondary objective is to determine the sites of failure and to estimate the time to failure and survival time following such an IP regimen. The protocol also has as one of its goals the determination of prognostic factors for disease progression and laparoscopic inspection of the peritoneum to determine the extent of residual disease prior to initiation of treatment. Patients with positive CA-125 will be followed for the response of that marker. Patients who develop neuro or renal toxicity will be switched from cisplatin to carboplatin as appropriate.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000096-46
Application #
7605769
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-04-01
Project End
2008-03-31
Budget Start
2007-04-01
Budget End
2008-03-31
Support Year
46
Fiscal Year
2007
Total Cost
$5,128
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016
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