59
Participants
Start Date
April 30, 2004
Primary Completion Date
February 29, 2008
Study Completion Date
January 31, 2009
Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Capecitabine
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
Radiation therapy
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Wellstar Cancer Research, Marietta
Atlanta Cancer Care, Atlanta
Northeast Georgia Medical Center, Gainesville
Integrated Community Oncology Network, Jacksonville
Tennessee Oncology, Nashville
Consultants in Blood Disorders and Cancer, Louisville
Tower Oncology, Beverly Hills
Collaborators (2)
Sanofi-Synthelabo
INDUSTRY
Aventis Pharmaceuticals
INDUSTRY
SCRI Development Innovations, LLC
OTHER