Intraperitoneal Floxuridine in Gastric Carcinoma

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, April 2003

Sponsored by:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00058916

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

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Floxuridine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intraperitoneal Floxuridine in Gastric Carcinoma

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	25
Study Start Date:	September 2002

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Resectable gastric cancer beyond stage T1N0M0
Normal organ function (marrow, kidneys, liver)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058916

Locations

United States, California
University of Southern California	Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Agustin A Garcia, MD 323-865-0470 AAGarcia@hsc.usc.edu
Contact: Heinz-Josef Lenz, MD 323 865 3055 lenz@hsc.usc.edu
United States, New York
New York University School of Medicine	Recruiting
New York, New York, United States, 10016
Contact: Franco M Muggia, MD 212-263-6485 franco@muggia.com
Contact: Elliot Newman, MD 212 263 7302 elliot.newman@med.nyu.edu
Principal Investigator: Franco M Muggia, MD

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

Study ID Numbers:	2150
Study First Received:	April 14, 2003
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00058916
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Floxuridine
Gastrointestinal Diseases

Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009