275
Participants
Start Date
September 30, 2006
Primary Completion Date
April 30, 2010
Study Completion Date
April 30, 2010
Docetaxel + Oxaliplatin
"Dose level 1 (non-optimal dose):~Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1~Dose level 2 (optimal dose):~Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1"
Docetaxel + Oxaliplatin + 5-FU
"Dose level 1 (non-optimal dose):~Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1.~Dose level 2 (optimal dose):~Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1."
Docetaxel + Oxaliplatin + Capecitabine
"Dose level 1 (optimal dose):~Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously.~Dose level 2 (non-optimal dose):~Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously."
Sanofi-Aventis Administrative Office, Bridgewater
Sanofi-Aventis Administrative Office, Diegem
Sanofi-Aventis Administrative Office, Paris
Sanofi-Aventis Administrative Office, Frankfurt
Sanofi-Aventis Administrative Office, Budapest
Sanofi-Aventis Administrative Office, Milan
Sanofi-Aventis Administrative Office, Porto Salvo
Sanofi-Aventis Administrative Office, Moscow
Sanofi-Aventis Administrative Office, Barcelona
Sanofi-Aventis Administrative Office, Geneva
Sanofi-Aventis Administrative Office, Istanbul
Sanofi-Aventis Administrative Office, Guildford Surrey
Lead Sponsor
Sanofi
INDUSTRY