Non Small Cell Lung Cancer
Conditions
Brief summary
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
Interventions
DRUGoxaliplatine / gemcitabine / Vinorelbine
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS), Overall survival (OS) | — |
Countries
France
Outcome results
None listed