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