Docetaxel and Oxaliplatin in Gastric Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

275

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Stomach Neoplasms
Interventions
DRUG

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"

DRUG

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."

DRUG

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."

Trial Locations (12)

Unknown

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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY