A Randomized Phase II Study of Docetaxel in Combination With Oxaliplatin With or Without 5-FU or Capecitabine in Metastatic or Locally Recurrent Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease

Inclusion Criteria

Inclusion criteria:

- Histologically proven gastric adenocarcinoma, including adenocarcinoma of the
gastro-oesophageal junction

- Metastatic or locally recurrent disease

- Prior adjuvant (and/or neo-adjuvant) chemotherapy with 5-Fluorouracil, Cisplatin,
epirubicin is allowed provided that the patient has relapsed > 12 months after the
end of the chemotherapy

- Performance status Karnofsky index > 70

- Hematology within 7 days before randomization:Hemoglobin ≥10g/dl, Absolute Neutrophil
Count ≥2.0 10^9/L, platelets ≥100 x 10^9/L

- Blood chemistry within 7 days before randomization:Total bilirubin ≤1x Upper Normal
Limit(UNL), Aspartate Aminotransferase (AST) Serum Glutamic Oxaloacetic Transaminase
SGOT) and Alanine Aminotransferase (ALT)Serum Glutamate Pyruvate Transaminase(SGPT)
≤2.5xUNL, alkaline phosphatase ≤ 5x UNL, provided that AST or ALT > 1.5 x UNL is not
associated with alkaline phosphatase > 2.5 x UNL; creatinine ≤1.25x UNL or 1.25x UNL
< creatinine ≤1.5x UNL and calculated/measured creatinine clearance ≥60 ml/min)

- Measurable and/or evaluable metastatic disease

Exclusion criteria:

- Any prior palliative chemotherapy

- Neurosensory symptoms National Cancer Institute Common Toxicity Criteria for Adverse
Events grade≥2

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.