A Safety and Efficacy Study in Patients With Gastric Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,053

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

March 31, 2008

Study Completion Date

April 30, 2008

Conditions
Gastric Cancer
Interventions
DRUG

S-1/Cisplatin

"In Arm A, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth (NPO 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with approximately 8 ounces of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour IV infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin."

DRUG

5-FU/cisplatin

In Arm B, 5-FU 1000 mg/m2/24 hours was administered CIV on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment for cisplatin.

Trial Locations (33)

10532

Hoo Chun, MD, Hawthorne

10956

Hematology/Oncology Associates of Rockland, New City

19104

Abramson Cancer Center, Philadelphia

19107

Thomas Jefferson University, Philadelphia

28560

New Bern Cancer Care, New Bern

29406

Charleston Cancer Center, Charleston

33308

Broward Oncology Associates, Fort Lauderdale

33401

Palm Beach Cancer Institute, West Palm Beach

33606

Alexandar Rosemurgy, Tampa

35801

Clearview Cancer Center, Huntsville

37404

Associates in Oncology and Hematology, Chattanooga

Lexington Oncology Associates, Chattanooga

53792

University of Wisconsin Comprehensive Cancer Center, Madison

55802

St. Lukes Cancer Care Center, Duluth

60611

Robert H. Lurie Comprehensive Cancer Center, Chicago

63110

Neuroscience Center, St Louis

St. Louis University Cancer Center, St Louis

70006

Oncology and Hematology, Metairie

77030

MD Anderson Cancer Center, Houston

80215

Western Hematology/Oncology, Lakewood

87102

AHS Lovelace Medical Group,LLC, Albuquerque

87106

New Mexico Cancer Center Associates, Albuquerque

University of New Mexico, Albuquerque

89106

Southern Nevada Cancer Research Foundation, Las Vegas

90033

Norris Cancer Center, Los Angeles

90404

Premiere Oncology, Santa Monica

91505

Saint Joseph Medical Center, Burbank

92262

Comprehensive Cancer Center, Palm Springs

94109

Saint Francis Memorial Hospital, San Francisco

95020

Dr. Ronald Yanagihara, Gilroy

96813

Straub Clinic and Hospital, Honolulu

60637-1470

University of Chicago Medical Center, Chicago

H2X3J4

CHUM Hopital Saint-Luc, Montreal

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Taiho Oncology, Inc.

INDUSTRY

NCT00400179 - A Safety and Efficacy Study in Patients With Gastric Cancer | Biotech Hunter | Biotech Hunter