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Intraperitoneal Floxuridine in Gastric Carcinoma

This study is currently recruiting patients.

Sponsored by: FDA Office of Orphan Products Development
Information provided by: FDA Office of Orphan Products Development

Purpose

Patients undergoing curative resection for gastric cancer have been shown to benefit from postoperative chemotherapy with 5-fluoruracil + leucovorin, and radiation in an Intergroup Study (INT116). However, both local and distal relapses still occur in 50% at 3 years. This study is based on the hypothesis that 2 cycles (of 3 days each 2 weeks apart) of intraperitoneal FUDR (floxuridine), followed by the above treatment will improve outcome.

Condition Treatment or Intervention Phase
Stomach Neoplasms
  Drug: fluorodeoxyuridine (FUDR)
 Phase I
Phase II

MedlinePlus related topics:  Stomach Cancer

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  25

Study start: September 2002

Eligibility

Genders Eligible for Study:  Both

Criteria


Location and Contact Information


California
      University of Southern California, Los Angeles,  California,  90033,  United States; Not yet recruiting
Agustin A Garcia, MD  323-865-0470    AAGarcia@hsc.usc.edu 
Heinz-Josef Lenz, MD  323 865 3055    lenz@hsc.usc.edu 

New York
      New York University School of Medicine, New York,  New York,  10016,  United States; Recruiting
Franco M Muggia, MD  212-263-6485    franco@muggia.com 
Elliot Newman, MD  212 263 7302    elliot.newman@med.nyu.edu 
Franco M Muggia, MD,  Principal Investigator

More Information

Study ID Numbers:  2150
Record last reviewed:  April 2003
Record first received:  April 14, 2003
ClinicalTrials.gov Identifier:  NCT00058916
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09
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