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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Neoadjuvant Irinotecan and Cisplatin Followed by Surgery Then Adjuvant Intraperitoneal Floxuridine and Cisplatin in Patients with Gastric Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Pharmaceutical / Industry	NYU-9822 P-UPJOHN-647597196, NCI-G99-1594, NCT00004103

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with surgery may kill more tumor cells.

This phase II trial is studying how well irinotecan and cisplatin followed by surgery, floxuridine, and cisplatin work in treating patients with stomach cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous chemotherapy, radiation therapy, or surgery for stomach cancer
• No metastases
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive infusions of cisplatin and irinotecan once a week for 4 weeks. Treatment will be repeated 2 weeks later. Patients will undergo surgery 4 weeks after the last chemotherapy dose. One week after surgery, some patients will receive an intraperitoneal infusion of floxuridine on days 1-3 and 22-24 and an intraperitoneal infusion of cisplatin on days 3 and 24.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NYU Cancer Institute at New York University Medical Center

Howard Hochster, MD, Protocol chair		Ph: 212-731-5100 Email: howard.hochster@med.nyu.edu

Registry Information
Official Title		A Phase II Study of Systemic Therapy with CPT-11 (Camptosar HCl) and Cisplatin in Patients with Advanced Gastric Cancer to be Followed by Surgical Resection and Postoperative Intraperitoneal Chemotherapy
Trial Start Date		1998-07-23
Registered in ClinicalTrials.gov		NCT00004103
Date Submitted to PDQ		1999-09-10
Information Last Verified		2005-12-07
NCI Grant/Contract Number		P30-CA16087

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