24
Participants
Start Date
February 28, 2006
Primary Completion Date
September 30, 2010
Study Completion Date
September 30, 2010
S-1/Cisplatin
"S-1 administration will be determined by degree of renal impairment as follows:~Group A (Control): 30 mg/m2 BID Group B (Mild renal dysfunction): 30 mg/m2 BID Group C (Moderate renal dysfunction): 20 mg/m2 BID Group D (Severe renal dysfunction): 20 mg/m2 QD~Pharmacokinetic Phase (Part 1):~On Days -2 and 14 of the Pharmacokinetic Phase, patients will receive a single dose of S-1 administered orally in the morning.~Treatment will be followed by 1 week of recovery (Days 15 through 21).~Extension Phase (Part 2):~S-1 will be administered orally for 2 weeks (Day 1 through Day 14) followed by a 1-week recovery period (Day 15 through Day 21). This cycle will be repeated every 3 weeks."
University of Maryland/Greenebaum Cancer Center, Baltimore
University of Kentucky/Division of Hematology/Oncology and Blood Marrow Transplantation, Lexington
Washington University School of Medicine, St Louis
The Institute for Drug Development, San Antonio
Premiere Oncology of Arizona, Scottsdale
Cancer Research & Treatment Center/University of New Mexico, Albuquerque
LAC/USC Medical Center, Los Angeles
Premiere Oncology, Santa Monica
Yale Cancer Center, New Haven
Taiho Oncology, Inc.
INDUSTRY