180
Participants
Start Date
July 31, 2005
Primary Completion Date
January 31, 2007
Study Completion Date
June 30, 2007
S-1
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 28 repeated 6 weeks.
S-1 plus CDDP
S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 21 with a single dose of CDDP 60 mg/m2 will be administered as an 1- to 3-hour IV infusion following the morning dose of S-1 on Day 8. The combination therapy will be repeated every 5 weeks.
5-FU plus CDDP
5-FU 600 mg/m2/24 hours administered intravenously as a CI over 120 hours (Days 1 through 5) along with a 30-minute infusion CDDP 20 mg/m2 from Day 1 through Day 5. The control treatment arm will be repeated every 4 weeks.
Beijing Cancer Hospital, No.52 Fu-Cheng Road, Hai-dian District
Taiho Pharmaceutical Co., Ltd.
INDUSTRY