Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients
- Conditions
- Non Small Cell Lung Cancer
- Registration Number
- NCT00271271
- Lead Sponsor
- Sanofi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
-
Non-small cell bronchopulmonary cancer established by histological and/or cytological methods;
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Advanced or metastatic disease (stage IIIB or IV);
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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;
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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;
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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;
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Informed consent form signed before any procedure undertaken connected with the study
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Objective rate of response (ORR) according to the RECIST criterion, as evaluated by a review panel of outside experts.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS), Overall survival (OS)
Trial Locations
- Locations (1)
Sanofi-Aventis
🇫🇷Paris, France