Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Study Overview
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Brief Summary
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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

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

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: oxaliplatine / gemcitabine / Vinorelbine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxaliplatine / gemcitabine / Vinorelbine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS), Overall survival (OS) |  |  |