Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Inclusion criteria

• Non-small cell bronchopulmonary cancer established by histological and/or cytological methods;
• Advanced or metastatic disease (stage IIIB or IV);
• At least one measurable lesion with one dimension (>= 20 mm by CT scan or >=10 mm by CT scan) outside of the irradiated area;
• No prior chemotherapy;
• Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks;
• Age >= 18 years old;
• ECOG Performance Status (PS): 0-1;
• Life expectancy >3 months;
• Hepatic and renal functions and blood count satisfactory:

• Blood counts: white blood cells >= 3.0 x 10^9/l, neutrophils >= 1.5 x 10^9/l, platelets >= 150 x 10^9/l, haemoglobin >= 9 g/dl,
• Hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (AST) or alanine transaminases (ALT) <= 2.5 times the normal upper value
• Renal function: creatinine clearance (calculated according to Cockroft and Gault) >= 40 ml/min;
• Patients of reproductive age must use an effective contraceptive method;
• Informed consent form signed before any procedure undertaken connected with the study

Exclusion criteria

• Pregnant or breastfeeding patient;
• Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix);
• Symptomatic cerebral or leptomeningeal metastases;
• Symptomatic peripheral neuropathy > 1 (NCI-CTC grade);
• Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator);
• Treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study;
• Concomitant treatment by any other anticancer therapy;
• Concomitant treatment with phenytoin.

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