Taxotere New Indication - Gastric Cancer Treatment Registration Trial

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.