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

Alternate Title

Phase III Randomized Study of S-1 and Cisplatin Versus Fluorouracil and Cisplatin in Patients With Unresectable Locally Advanced or Metastatic Gastric Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry TAIHO-TPU-S1301 QUINT-TPU-S1301, NCT00400179

Trial Description

Purpose:

Drugs used in chemotherapy, such as S-1, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether S-1 and cisplatin are more effective than fluorouracil and cisplatin in treating gastric cancer.

This randomized phase III trial is studying S-1 and cisplatin to see how well they work compared to fluorouracil and cisplatin in treating patients with locally advanced or metastatic gastric cancer that cannot be removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• No brain or leptomeningeal metastases
• More than 5 years since biological therapy, chemotherapy, or hormone therapy for this cancer
• At least 4 weeks since radiation therapy
• At least 3 weeks since surgery
• 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 be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive a 1- to 3-hour infusion of cisplatin in week 1. They will also receive S-1 by mouth twice a day in weeks 1-3. Treatment with cisplatin and S-1 may repeat every 4 weeks for up to six courses. Patients will then receive S-1 alone twice a day for 3 weeks. Treatment with S-1 alone may repeat every 4 weeks for as long as benefit is shown.

Patients in group two will receive a 1- to 3-hour infusion of cisplatin and a 5-day continuous infusion of fluorouracil in week 1. Treatment with cisplatin and fluorouracil may repeat every 4 weeks for up to six courses. Patients will then receive a 5-day continuous infusion of fluorouracil alone every 4 weeks for as long as benefit is shown.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated every 2 months for up to 5 years.

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

Taiho Pharma U.S.A., Incorporated

Jaffer Ajani, MD, Principal investigator		Ph: 713-792-2828; 800-392-1611 Email: jajani@mdanderson.org

U.S.A.
California
	Gilroy
	Medical Oncology/Hematology
		Ronald Yanagihara, MD	Ph:  408-847-6194
			Email: ron@ryanagihara.com
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Heinz-Josef Lenz, MD	Ph:  323-865-3967
			Email: lenz_h@ccnt.usc.edu
	Palm Springs
	Desert Regional Medical Center Comprehensive Cancer Center
		Lawrence Leichman, MD	Ph:  760-416-4734
Florida
	Fort Lauderdale
	Broward Oncology Associates
		Luis Barreras, MD, FACP	Ph:  954-771-0692
			Email: barrerasl@mindspring.com
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Alexander Rosemurgy, MD	Ph:  813-844-4218
			Email: arosemur@hsc.usf.edu
Hawaii
	Honolulu
	Straub Clinic and Hospital, Incorporated
		C. Galen Choy, MD	Ph:  808-522-4333 800-232-9491
			Email: gchoy@straub.net
Illinois
	Chicago
	Robert H. Lurie Comprehensive Cancer Center at Northwestern University
		Clinical Trials Office - Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Ph:  312-695-1301
			Email: cancer@northwestern.edu
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		Joel Picus, MD	Ph:  314-747-3575
New Mexico
	Albuquerque
	Lovelace Medical Center - Downtown
		Dennie Jones, MD	Ph:  505-262-7170
	University of New Mexico Cancer Center
		Clinical Trials Office - University of New Mexico Cancer Center	Ph:  505-272-6972
New York
	New City
	Hematology-Oncology Associates of Rockland, PC
		Robert March, MD	Ph:  845-348-8507
			Email: rmarch@rocklandhemonc.com
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Edith Mitchell, MD, FACP	Ph:  215-955-6961
			Email: Edith.Mitchel@jefferson.edu
South Carolina
	Charleston
	Charleston Cancer Center
		Charles Graham, MD	Ph:  843-576-1006
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Daniel Mulkerin, MD	Ph:  608-263-9912

Registry Information
Official Title		An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 in Combination with Cisplatin Compared Against 5-FU in Combination with Cisplatin in Patients with Advanced Gastric Cancer Previously Untreated with Chemotherapy for Advanced Disease
Trial Start Date		2005-04-01
Registered in ClinicalTrials.gov		NCT00400179
Date Submitted to PDQ		2005-07-21
Information Last Verified		2007-09-30