Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Inclusion Criteria: * Gastric adenocarcinoma including adenocarcinoma of the esophagogastric junction, histologically proven. * Measurable and/or evaluable metastatic disease; if a single metastatic lesion is the only manifestation of the disease, cytology or histology is mandatory. Locally recurrent disease is accepted provided that there is at least one measurable lesion. * Performance status Karnofsky index \>70% * Life expectancy of more than 3 months * Adequate haematological parameters (Hb≥9g/dl, ANC≥2.0× 109/L, platelets ≥ 100× 109/L) * Creatinine ≤ 1.25 UNL, serum magnesium should be within the normal value * Total bilirubin ≤ 1 UNL, AST and ALT ≤ 2.5 UNL, alkaline phosphatase ≤ 5 UNL * No prior palliative chemotherapy, previous adjuvant chemotherapy is allowed if more than 12 months has elapsed between the end of adjuvant therapy and first relapse. * At least 6 weeks from prior radiotherapy and 3 weeks from surgery * Complete initial work-up within two weeks prior to first infusion for clinical evaluation and biological work-up. Abdominal CT scan and chest X-rays are mandatory. Exclusion Criteria: * Pregnant or lactating women * Patients with reproductive potential not implementing adequate contraceptive measures * Other tumor type than adenocarcinoma * Any prior palliative chemotherapy. Prior adjuvant chemotherapy with a first relapse within 12 months from the end of adjuvant * Prior treatment with taxanes. Prior CDDP as adjuvant chemotherapy with cumulative dose \> 300mg/m² * Previous or current malignancies other than gastric carcinoma, with the exception of adequately treated in situ carcinoma of the cervix uteri or non melanoma skin cancer * Patients with known brain or leptomeningeal metastases * Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria * Other serious illness or medical conditions: * unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry * history of significant neurologic or psychiatric disorders including dementia or seizures * active uncontrolled infection * active disseminated intravascular coagulation * other serious underlying medical conditions which could impair the ability of the patient to participate in the study * Concurrent treatment with corticosteroids except as use for the prophylactic medication regimen, treatment of acute hypersensitivity reactions or unless chronic treatment at low doses * Definite contraindications for the use of corticosteroids * Hypercalcemia not controlled by bisphosphonates and more than 12mg/100ml * Liver impairment with AST or ALT more than 1.5UNL associated with alkaline phosphatase more than 2.5UNL * Concurrent or within 4 week period administration of any other experimental drugs * Concurrent treatment with any other anti-cancer therapy The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.