Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer

Primary:

·To evaluate the activity of the combination of gemcitabine, oxaliplatin and vinorelbine as first line treatment in patients with non-small cell bronchopulmonary cancer

Secondary:

·To evaluate the toxicity of the combination

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.